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CNN PRESENTS

Selling a Miracle

Aired May 20, 2012 - 20:00   ET

THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.


DREW GRIFFIN, CNN PRESENTS HOST: What would you do if your child had an incurable disease? And a doctor offered you a miracle?

STEPHANIE KROLICK, CASH'S MOTHER: I went home that night, and I cried my eyes out. Because I knew that somehow we had to do this.

GRIFFIN: The hope. The hype. And the heartache. Chasing a stem cell cure.

DR. WISE YOUNG, RUTGERS UNIVERSITY They're calculated to take a family to the brink of what they can afford. And they take everything.

JAN PUZNI, SPECIAL EDUCATION TEACHER: Come on. Around here. I want you to sit down. OK? Go over and sit down. And we'll have some pineapple.

GRIFFIN: Six-year-old Cash Burnaman is a boy who needs a lot of attention.

PUZNI: Your turn.

GRIFFIN: And here at Mitchell Road Elementary in Greenville, South Carolina, he's getting it. From special education teacher Jan Puzni.

PUZNI: Can you say please? Tell me, please. OK. That's good. Thank you. Good. Come on. Now Cash was not able to do this puzzle just a month ago. So he's made great progress there. Good job, Cash. That went in just like that.

GRIFFIN: Cash was born with a rare chromosome abnormality. His condition is, according to his mom, Stephanie, incurable.

KROLICK: He is missing part of his X and another part of it is repeated. It's very rare. Or even unique.

GRIFFIN (on camera): What did they tell you his life was going to be?

KROLICK: They said they didn't know.

(LAUGHTER)

I'll be really honest and tell you, I never went back to the geneticist because I felt like -- I felt like they wanted to watch and learn because they didn't know. He's had a very hard time walking. He has a very hard time with fine motor skills. And so those are two of the biggies.

PUZNI: Which way we going?

GRIFFIN (voice-over): Cash still isn't toilet trained. He has very low muscle tone. He has to take a daily artificial growth hormone. He's prone to pneumonia. His mother says he has some traits associated with down syndrome. And he's mute.

(On camera): A rough life. And a hard life for you.

KROLICK: Yes. When he was really little, that still allowed us to have a lot of hope. But as he got older, it became more and more clear that, no, we had -- that was our reality. That he was going to -- and in fact, pretty severely. It's hard for me to even say that. Even now.

GRIFFIN: Because?

KROLICK: Because he's my normal. So I don't like to think of the ways that he isn't like everyone else. I like to think of all the things he's great at.

GRIFFIN (voice-over): Stephanie and Cash's dad, Josh Burnaman, were divorced two years ago. But as they were breaking up, Stephanie heard about a treatment in India that she believed could help her son. A doctor who was willing to say there was hope. Embryonic stem cells being injected into incurable patients like Cash. And patients, reportedly, who were showing signs of improvement. But there were no formal studies, just what was available on the Internet.

KROLICK: And it's risky medical therapy, but I knew that we were going to have to do it.

GRIFFIN (on camera): Where's the studies? Where's the science?

KROLICK: We did pick this clinic for a reason. I mean, we did look around, and we decided that this was the place where we felt safe, like she had a good track record.

GRIFFIN (voice-over): Late in 2010 Stephanie Krolick, Josh Burnaman and their son, Cash, spent five weeks in New Delhi at a clinic where a doctor said she would inject embryonic stem cells into Cash's little body. Stephanie Krolick says before that visit, Cash could not walk. He stumbled. Now, with the help of braces, he carefully maneuvers on the sidewalk outside the apartment where he lives. It has made Stephanie a believer.

(On camera): Anybody who has kids can tell you, my kid was crawling, then my kid was walking. It happened overnight. Maybe this was just his time to walk.

KROLICK: That's true.

GRIFFIN: Have you considered that? KROLICK: Yes, absolutely.

GRIFFIN: So tell me what you would say to all those people watching this who never met Cash, who never had a child like Cash, who are going to be judgmental of you, wondering if you're wasting your money. Why are you doing this?

KROLICK: We saw enough evidence from the first time that it's worth trying again. In this particular case, with Cash's other conditions, we don't have many other options. Any really other options.

GRIFFIN (voice-over): So Stephanie and Josh decided to take their son to India for a second time. To the very same clinic. And this time, CNN is going, too.

For Stephanie Krolick, the cost of both trips will be more than $50,000. At his home office in Madison, Wisconsin, Steven Byer wishes them well. He's never met them, but is convinced they are being ripped off.

STEVEN BYER, BEN'S FATHER: The bigger the disease, the greater the predator. So they're preying on people who have terminal illness and their families.

GRIFFIN: How does he know? Byer's son, Ben, was diagnosed with Lou Gehrig's disease in 2002. They were told it was incurable. The Byers refused to believe it. And they were just as desperate as Stephanie Krolick.

(On camera): Did you begin searching for a cure?

S. BYER: From day one.

GRIFFIN (voice-over): Searching the world for a miracle cure and finding a world of clinics willing to take their money. When we come back --

BARBARA BYER, BEN'S MOTHER: We expected that there would be something somewhere on the planet that would help.

(COMMERCIAL BREAK)

(BEGIN VIDEO CLIP)

BEN BYER, FILMMAKER: Yes. Yes. I have Lou Gehrig's disease. G-E-H-R-I-G, apostrophe S.

(END VIDEO CLIP)

GRIFFIN (voice-over): Ben Byer was 31, an actor and a playwright when he was diagnosed with Lou Gehrig's disease, ALS, a disease that is always fatal. He began a video diary that ultimately turned into this full-length documentary that he called "Indestructible."

B. BYER: They -- they have more treatment for the -- the -- the flu than they do for this disease.

GRIFFIN (on camera): Did you know --

BARBARA BYER: Nothing.

GRIFFIN: -- what that was?

BARBARA BYER: Absolutely nothing. I had no idea about ALS. I mean, I'd heard about people having ALS and it was a horrible disease and I didn't want to know any more.

GRIFFIN (voice-over): Steven and Barbara Byer were his parents.

S. BYER: At the time, and mind you, this was eight or nine years ago, Ben was given what we call the ALS speech. Which is now still given, but not as frequently as it was then. And the speech is, gee, I'm terribly sorry, you have ALS. You're going to die in one to three years.

B. BYER: My body is about 15 percent dead. But I'm also 85 percent alive.

GRIFFIN: But the Byers wouldn't accept that their son's death was inevitable.

BARBARA BYER: We expected that there would be something somewhere on the planet that would help. That even if they didn't have something here in the U.S., surely in other countries, somewhere, we would find an answer.

GRIFFIN: That search led them to a doctor in China offering a miracle concoction that looked and tasted like sewage. Ben Byer drank it for six years. They went to Greece. Another treatment. It didn't work. Then finally again back to China, where a doctor using stem cells extracted from the nose of an aborted fetus was willing to inject those embryonic stem cells directly into Ben's brain.

S. BYER: He was doing it for a spinal cord injury and multiple sclerosis and cerebral palsy and then he decided to do it for ALS when there was a queue of patients with ALS who were waiting for the surgery.

B. BYER: There is something to it. Otherwise I don't think that we'd be here.

GRIFFIN: The eventual surgery was videotaped.

(On camera): This sounds like the magical cure overseas that you were looking for.

BARBARA BYER: Well, I did think it was. I thought this was going to be it. We found it. He'll have it. He'll be great. And, actually, we were planning his sister's wedding that summer. And I pictured him -- but it didn't happen.

GRIFFIN (voice-over): A month after the surgery, still filming his journey, Ben Byer admitted to his sister, there was no change.

UNIDENTIFIED FEMALE: So are you disappointed?

B. BYER: Yes. I'm obviously disappointed. Just I wanted to be sure.

S. BYER: I realize that in some ways, we were duped. We duped ourselves. We looked at the very best, and we didn't explore the very worst.

GRIFFIN: Ben Byer died four years later. He was 37.

(On camera): He believed until the day he died it could have worked?

BARBARA BYER: He believed that it could have worked. That it was worth the risk to try it. Unfortunately, there are many predators out there who will really offer you nothing which you'll pay for.

GRIFFIN (voice-over): Now the Byers run a foundation on behalf of their son. One of its main goals is just to warn people in similar situations about the perils of stem cell treatment overseas.

S. BYER: I have a phrase. Everybody has a phrase. The bigger the disease, the greater the predator. So they're preying on people who have terminal illness and their families.

GRIFFIN: He gets phone calls every day from people wanting to go to China and, lately, India, for the miracle stem cell therapy they can't get in the United States. The FDA has yet to approve any embryonic stem cell therapy in this country. Byer has given up telling so many desperate people not to go.

S. BYER: Now when somebody is absolutely committed to go, I don't say, you're wrong. You're wrong. At that point, I kind of capitulate. And I say, listen, I wish you the very best. I want you to prove me wrong. Call me when you get back or a month afterwards and tell me how you're doing. I'd love to hear that you're the exception to the rule. And God willing, you will be.

GRIFFIN (on camera): You haven't heard that yet, though, have you?

BARBARA BYER: No.

S. BYER: Doesn't happen.

GRIFFIN (voice-over): And yes, the clinic where Stephanie Krolick is about to take her son for the second time is on their list. The Byers believe it's among those offering worthless treatments to desperate people.

S. BYER: They provide a -- again, a one-size-fits-all type of stem cell procedure for any disease and every disease who applies. And it doesn't work for any of them. BARBARA BYER: The doctors who do this or the physicians or the scientists or the scam artists that for some of them, it is the thrill of making the money. They're just pure predators. And for others, they may have something of a god complex where they feel that they're really giving a gift to these patients or giving them a sense of hope. Somehow in their minds, even though they're not really giving them anything, they feel like they're giving them this empty vessel of hope.

GRIFFIN: Back at her apartment in South Carolina, Stephanie Krolick has heard the warnings. She just refuses to believe them.

(On camera): Have you considered at all the fact that this wonderful doctor in India may be feeding you a line of bull?

KROLICK: Yes. Yes, I have. I remember a week in last time thinking, oh, my gosh, what are we doing? We're here. We've spent all this money. And so many people have given, been so generous to us, so kind. So many people have so much hope. And we're buying snake oil.

GRIFFIN (voice-over): Next --

(On camera): are you curing them?

(Voice-over): The doctor offering hope for the hopeless.

DR. GEETA SHROFF, NU TECH MEDIWORLD: We are healing the injured site. Because these stem cells go and repair and regenerate.

(COMMERCIAL BREAK)

GRIFFIN (voice-over): It's Thanksgiving weekend at the airport in Greenville, South Carolina.

UNIDENTIFIED MALE: Ma'am, can I help you with that bag? Anything I can do for you?

KROLICK: Yes, please.

GRIFFIN: Stephanie Krolick and her ex-husband, Josh, are struggling to unload the bags and a stroller and get their 6-year-old son, Cash, into the terminal for the start of a very long trip to India.

UNIDENTIFIED MALE: Be careful. Careful.

GRIFFIN: This will not be a cheap trip.

KROLICK: I knew that it's very, very, very expensive. That money just doesn't exist in our lives. Let's go that way.

GRIFFIN: The actual cost for travel, treatment, housing, all the extras, around $25,000. Which the family raised during a year's worth of fundraising. Anchored by this blog, changeforcash.com. Critics of what the family is about to do say even the price of treatment should raise a warning.

YOUNG: It's all about $25,000. You know, in the days when Volkswagens are $6,000, that's how much, you know, these cures cost. Now they're $25,000. They're calculated to take a family to the brink of what they can afford. And they take everything.

GRIFFIN: Dr. Wise Young is one of the U.S.'s leading neuroscientists. And has investigated the very clinic in India where Cash will be treated by Dr. Geeta Shroff.

YOUNG: There's zero evidence for what she is doing. That being effective. She's charging patients a lot of money for this. And she has not published. And to my knowledge, there's no evidence at all that her therapies are effective. No Indian doctor I know would be allowed to practice this.

GRIFFIN: At the airport in South Carolina, Stephanie Krolick is actually preparing to say good-bye. By prearrangement, her ex-husband will take Cash to India for the first two weeks of treatment. She will join them just before Christmas.

KROLICK: Let's say good-bye. I know. I don't want to say good- bye to you. I don't want to say good-bye. I'm going to miss you a whole, whole, whole lot. I love you.

UNIDENTIFIED MALE: Say good-bye, mom.

KROLICK: Good-bye.

GRIFFIN: The beginning of a long, long journey.

KROLICK: Bye, little love.

GRIFFIN: A journey which eventually winds up here, in a tiny room at a small clinic.

(On camera): It may seem an improbable place to come to find a cure for incurable ailments, but Cash is by no means alone. So far, 87 Americans have come here to this neighborhood in Delhi, believing that the answers to their incurable medical conditions are found right here.

SHROFF: About 90 percent kind of a cure.

GRIFFIN: This is Dr. Geeta Shroff who runs Nu Tech Mediworld. She says she began her medical career delivering babies, morphed into an infertility specialist, and finally she operates the only clinic on the planet, she says, using embryonic stem cells to treat disease on an everyday basis.

(On camera): How many patients do you have a day here?

SHROFF: Plenty.

GRIFFIN: Plenty. From all over the world?

SHROFF: Yes.

GRIFFIN (voice-over): When she gives us a tour, patients are, indeed, from everywhere. With an astonishing array of severe problems.

SHROFF: He's getting his injection, yes.

GRIFFIN: This man is from Baghdad. A paraplegic because of multiple gunshot wounds.

(On camera): So is this your first time here?

UNIDENTIFIED MALE: Yes.

GRIFFIN (voice-over): This Indian toddler, she says, has a genetic disorder similar to the one affecting Cash. And this American teen was paralyzed three years ago in a motocross accident in southern Illinois.

UNIDENTIFIED MALE: Before I came here, I had, you know, no movement in my left hand between the fingers and stuff. Now I can contract them really good.

GRIFFIN (on camera): So that, what you're doing now, is --

UNIDENTIFIED MALE: Yes.

GRIFFIN: New?

UNIDENTIFIED MALE: Yes. That's new, for sure.

GRIFFIN (voice-over): It may seem like a tiny improvement. But it's the kind of thing Dr. Shroff likes to emphasize when she claims she is making the incurable better. Still, no other scientist, no published studies back up her claims.

(On camera): But you're taking ALS --

SHROFF: Mm-hmm. That's a neurodegenerative. So neurodegenerative I'm taking up as a group. Spinal cord injuries I take up as a group. Cerebral palsy and degenerative disorders I'm taking up. And what else am -- muscular skeletal disorders.

GRIFFIN: Are you curing them? What is the word you would use?

SHROFF: I am helping improve their quality of life.

GRIFFIN (voice-over): Nurses and attendants inject patients daily. Inject them with what Dr. Shroff claims are viable embryonic stem cells. All derived from a single embryo, she says, that she harvested years ago while an infertility specialist. Six-year-old Cash Burnaman winces as he gets his injections.

Shroff, who opened the doors of her clinic to CNN, would not take us to the lab where she says the embryonic stem cells themselves are manufactured. (On camera): Do you call yourself a pioneer? You seem to be very self taught in this regard.

SHROFF: Yes, I am.

GRIFFIN: A pioneer?

SHROFF: Maybe, yes. Maybe.

GRIFFIN: Inventor?

SHROFF: Yes. Because it's a totally different way of handling stem cells.

GRIFFIN (voice-over): Josh Burnaman brought his son, Cash, here because there is nowhere else to take him. His condition is incurable. He does hope for the best, but outside the clinic, in a park out of earshot of Dr. Geeta Shroff, Josh Burnaman openly wonders if he, his ex-wife, and especially Cash, are being duped.

(On camera): Is this working?

JOSH BURNAMAN, CASH'S FATHER: That's the most difficult question for me. Because I have to try to be objective about it. Because every time we go, we're investing a lot of money, tens of thousands of dollars. And a lot of time. The people at the hospital, you know, each day are saying, oh, I see this. You know, so I want to see those things. And I do see improvement. But to -- it's hard to know exactly what is due to stem cells and what is due to just his development.

GRIFFIN (voice-over): Ironically, he says, the very use of embryonic stem cells are his biggest worry.

BURNAMAN: The stem cells give us hope, but the hope is kind of a dangerous thing for parents with a disadvantaged child.

DR. JONATHAN GLASS, SURGEON: Ready? This is dangerous.

GRIFFIN: Ahead, what real hope is there? An exclusive look at what possible stem cell cures do exist in the United States. And exactly how risky even approved treatment can be.

GLASS: You're a hero, as far as I'm concerned.

(COMMERCIAL BREAK)

GRIFFIN (voice-over): This is what an approved experimental stem cell treatment procedure looks like in the United States. Doctors at Atlanta's Emory University Hospital are preparing to inject fetal stem cells into the neck and spinal cord of a patient who has ALS. Lou Gehrig's disease. It's never been done before. Anywhere.

DR. EVA FELDMAN, CLINICAL TRIAL LEADER: So we need to first ensure that it's safe. And then with the hopes, the great hopes that it's going to be efficacious and we are going to be able to help preserve respiratory function, breathing, in patients with ALS.

GRIFFIN: The patient, Rick Grosjean, was diagnosed only two years ago. Now he can barely speak. His wife, Tracy, does the talking.

TRACI GROSJEAN, PATIENT'S WIFE: He can still walk. He still works. He has trouble with his speech. A lot of people can't understand him. So, you know, I'm pretty much his voice for him.

GRIFFIN: Dr. Jonathan Glass talks them through what's about to happen. And he's blunt about what the stem cells won't do.

GLASS: You understand that we don't expect you to get better from this. And there is some risk involved.

GRIFFIN: That's because up until now stem cells have never been targeted in this specific area of the spine for his specific disease. This is the earliest stage of human testing. A stage one trial. Approved by the FDA. Designed not to cure, but to see what's safe. The lead surgeon is Dr. Nicolas Boulis who knows the dangers better than anyone.

DR. NICOLAS BOULIS, SURGEON: This patient that we're doing today is injection of the upper cervical spinal cord. So the stakes here are not only they can be put in a wheelchair, but that they could be quadriplegic. And they could have their ability to breathe affected.

GRIFFIN: The fetal stem cells arrive at the hospital only a little before his surgery. And before the surgery, they are processed with meticulous care. Technicians color them with dye. They go under a microscope to see which ones survived the trip and which didn't. The live stem cells are white. Dead are black.

During the four-hour procedure, the doctors say everything goes as planned. Boulis had to invent a device that looks like a tiny oil rig mounted on the patient's spine just to safely inject the stem cells. And it works.

BOULIS: I think it went really well. We're going to learn a lot about rejection of the cells, the need for immunosuppresion, the safety of the injections, the ability of an ALS patient to tolerate this kind of surgery.

GRIFFIN: But even though this surgery went well, the doctors and scientists here know that the history of fetal or embryonic stem cells showing dramatic documented progress in curing anything is dismal. And desperate Americans still ask, ask all the time.

FELDMAN: Almost every day I get one, usually two, three e-mails from patients with different neurologic diseases, primarily ALS. And they're asking me, should I go to China? Should I go to Mexico? Should I go to South America to get stem cell treatment?

DR. SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: There's been nothing that has been conclusively shown to work. GRIFFIN: Dr. Sanjay Gupta is CNN's chief medical correspondent and a neurosurgeon himself. He told us, despite the hype and the hope of stem cell therapy, there's been precious little in the way of a miracle cure. In fact, there have only been two FDA approved trials so far in the U.S.

GUPTA: One of them essentially shut down because it was so expensive to do, and another study looking at macular degeneration, which is a cause of blindness, especially among older people, it's an ongoing trial. They've done two patients. They say it's safe. They say those patients had a little bit of return of vision. But the answer is we just don't know yet in terms of what that promise really is going to be.

GRIFFIN: Which makes the claims and so-called success stories coming out of Dr. Geeta Shroff's clinic off this busy road in New Delhi so hard to believe.

FELDMAN: It's very unfortunate that stem cell operations offshore would take advantage of patients who feel very, very desperate. You know, the idea of stem cells is so appealing. So you think, oh, stem cells, you know. That will cure me. But when -- but you have to realize, of course, that the stem cells need to reach the proper target. You need to get into the spinal cord into the brain. And unless they're applied properly, there is no reason to think that they would be efficacious at all.

SHROFF: This child has also just started.

GRIFFIN: According to Dr. Shroff, she is doing what no other doctor in the world is doing. She is using embryonic stem cells to heal.

SHROFF: Yes, because --

GRIFFIN (on camera): Their bodies are improving?

SHROFF: No, we are healing --

GRIFFIN: You're not just training their bodies to adapt with the injury?

SHROFF: No. We are healing the injured site. Because these stem cells go and repair and regenerate.

GRIFFIN (voice-over): Every patient in her clinic is injected with what she claims are viable embryonic stem cells. Not in a controlled surgical environment with watchful eyes all around. But here. In an everyday environment. And this morning a nurse handles the injection at a young Cash Burnaman. He's been through it before, but still, he's hugging his father tight as the needle goes into the small of his back.

BURNAMAN: All done.

GRIFFIN: Even now, his dad just isn't sure. (On camera): There's a certain amount of improvement Cash is going to make just on his own and with all the loving care he gets.

BURNAMAN: Right, right. And, you know, if we had taken away the stem cells and hadn't done it, is this where he would be naturally? And that's where I keep coming back to is that, you know, I'm not sure.

GRIFFIN (voice-over): Ahead --

(On camera): How do you know it's working? How do you know the stem cell line that you've created and the injections into these incurable patients is actually working?

(Voice-over): Confronting the doctor in New Delhi who claims success with practically every patient who crosses her threshold.

(On camera): They still come.

SHROFF: They do.

GRIFFIN: And come back.

SHROFF: Yes, they do. Many times.

GRIFFIN: And you see improvements in their lives?

SHROFF: Yes.

(COMMERCIAL BREAK)

GRIFFIN (voice-over): Her clinic is not very far from some of New Delhi's most prestigious hospitals. With a modern glass front, Nu Tech Mediworld is both treatment center and hotel for American patients drawn by the hope and promise of embryonic stem cell therapy. For Americans, it's not cheap. The cost for 6-year-old Cash Burnaman's parents, Josh and Stephanie, a five-week stay, around $25,000. Cash is on his second visit. In all, this family will pay Shroff more than $50,000.

The doctor makes no excuses for the price.

(On camera): It costs an incredible amount of money for them to do this.

SHROFF: Yes, sure.

GRIFFIN: Fifty thousand or so?

SHROFF: Yes. But this usually is a period of three months in which you have the entire stem cell therapy, the medical care, food, lodging for two, food for two, the physical therapy, occupational therapy and medical care, as I said, around the clock.

GRIFFIN (voice-over): Lodging is not luxurious. Closet-size rooms, bathrooms down the hall. Cash, his dad and his grandfather will spend weeks in this small space.

(On camera): Your critics, many whom have never been here, say she's just getting rich.

SHROFF: Of course. Let them say it. Who doesn't want to get rich? Who doesn't work for money? But you also have to work from the heart. You also have to see what you're doing. Is it ethically right? And I believe that I'm doing everything right.

GRIFFIN (voice-over): According to Shroff, and a sliding scale of success she drew up based on the treatments she offers, her results are phenomenal.

SHROFF: As of right now, I would say almost everyone, let's say greater than 90 percent patients, have had success.

GRIFFIN: We asked CNN's Dr. Sanjay Gupta about Dr. Shroff's claims for success.

GUPTA: We just don't see any data coming from any of these other labs. If it works, if you've proven that it's safe, it's a pretty simple thing to publish it and have it looked at by your own peers.

GRIFFIN (on camera): This woman is either a miracle person in terms of embryonic stem cell research, or a fraud.

GUPTA: It's concerning no matter how you look at it. You can inject cells that are not pure in some way and you could potentially cause harm. If it's working and she's doing it the right way, she should write it up. I mean, that's what scientists do. That's what we've been trained to do.

GRIFFIN (voice-over): In fact, Dr. Shroff said she tried to submit some scientific papers on her work.

(On camera): You've tried to present this to the International Society of Stem Cell Research?

SHROFF: Yes. Twice.

GRIFFIN: They said don't even bother coming.

SHROFF: Yes. I sent one presentation last year, 2010, or was it 2009? I'm just mixed up a bit. And one in 2006. Both the times they said no. You can't come. You can't accept -- you can't come and read your paper.

GRIFFIN: They believe, in general, that you and others doing this are frauds.

SHROFF: But if we are frauds, then come pull us down. I'm willing to come to your den and talk there. Pull me down there if I'm a fraud.

GRIFFIN: You're not a fraud?

SHROFF: I'm not a fraud. Never a fraud. I refuse to be called that.

GRIFFIN: So that, what you're doing now is new?

UNIDENTIFIED MALE: Yes.

GRIFFIN (voice-over): All of the American patients here told us they did feel as if they improved. But since Dr. Shroff hasn't published any of her work in medical journals, won't let others, including us, see her lab where she says the embryonic stem cells are harvested, the world scientific community so far has shunned her.

(On camera): Why do you believe that the, quote-unquote, established medical community looks down on the work you're doing and is so critical?

SHROFF: I guess they are threatened. And any new science is always, you know, like questioned and criticized. And I'm not in the academics, I'm not in that world. So I don't know why they are.

GRIFFIN (voice-over): This man is one of her toughest critics. Dr. Wise Young. One of the world's most highly regarded neurologists. He's at Rutgers University.

YOUNG: It's a failure of India not to control her practice. She's charging patients a lot of money for this. And she has not published. And so this needs to stop. And I don't know why India has not stopped this.

GRIFFIN (on camera): What's your reaction to that?

SHROFF: Did an electrician discover electricity? Did he have background in electricity before that? My answer to him is keep your eyes open. My patient is out there. Comment on that and then talk to me. Just don't say things.

GRIFFIN (voice-over): As for 6-year-old Cash Burnaman Dr. Shroff says her injections have helped him. But on the sidewalk outside the clinic, for the first time, Stephanie Krolick began to have some doubts about the stem cell treatment Dr. Shroff was giving her son.

KROLICK: The very process of examining it again, talking to you guys -- excuse me -- talking to you, Drew, made me really think about why we were doing this. Whether or not it had worked. Whether or not I was fooling myself or being deluded. The amount of money, the amount of trouble, there will have to be significant enough changes for us to feel like it's worth it to do it again. But we'll see. I'm still -- you know, I'd love it if that happens.

GRIFFIN (on camera): Are you really helping these patients?

SHROFF: Yes.

GRIFFIN: Or are you really just helping yourself? SHROFF: I am helping these patients, and I'm helping myself. I'm helping these patients because there are documented, visible effects of the stem cells.

GRIFFIN: Are these miracles happening here?

SHROFF: No, it's science. But, yes, they're miracles, too. Why? Because they've never happened before.

GRIFFIN (voice-over): Coming up --

(On camera): Is there stem cell treatment proven in India that will make them better?

DR. P.N. TENDON, NEUROLOGIST: Well, I answer this question even in a stronger tone, not only proven in India, but not proven anywhere in the world.

GRIFFIN (voice-over): Dr. Geeta Shroff comes face to face with critics who want to shut down unregulated clinics like hers.

(On camera): Basically, they were saying you shouldn't be doing what you're doing.

(COMMERCIAL BREAK)

GRIFFIN (voice-over): On a Saturday morning in New Delhi, the men and women in this room are meeting to debate something they've spent six years trying to control. How to regulate stem cell therapy in their sprawling country. Results so far, zero. Because after six years, there aren't any laws. Only guidelines.

TANDON: These guidelines will remain only for those who are honest and want to follow the guidelines. It will not apply to people who are unethical and are still practicing.

GRIFFIN: This man is Dr. P.N. Tandon. Described to us as India's leading neurosurgeon and a past scientific adviser to India's prime minister. He says he's well aware that the current guidelines are virtually useless.

TANDON: No, I say with you, and I say that with all concern about it.

GRIFFIN: In fact, those guidelines are so loose and Indian bureaucracy so ponderous, getting straight answers isn't easy. Even from the government official in charge of medical research.

(On camera): But how do you handle the clinics that are not in clinical trials, that are not being supervised, that are using stem cell treatment experimentally to treat all sorts of ailments?

DR. V.K. KATOSH, INDIAN COUNCIL OF MEDICAL RESEARCH: See, I think this is getting all over the press, people have been asking this question to us, but I think as a science body chief, it's not appropriate for me to comment on that. Because if it is irregular, then it is to be handled to somebody else's section.

GRIFFIN (voice-over): We've spent the previous three days at the embryonic stem cell clinic run by Dr. Geeta Shroff. She'd never mentioned anything about the conference taking place to discuss exactly what she is doing. Which is why we were surprised when she walked in, sat down and listened as speaker after speaker railed against India's unregulated stem cell clinics.

UNIDENTIFIED MALE: Anybody and everybody has started to put some kind of cell in some part of the body obtained from some source, which is not really clear on this, charging huge amount of money to unsuspecting patients.

GRIFFIN (on camera): That was some pretty tough talk in there.

SHROFF: Yes.

GRIFFIN: Basically, they were saying you shouldn't be doing what you're doing.

SHROFF: No, they weren't saying that. They were saying we need stricter guidelines, stricter law, regulations, and I'm all for it. I wouldn't say they're targeting me here. Because they have been fully aware of what I do from the very beginning.

GRIFFIN (voice-over): With government regulators unconvinced Dr. Shroff is actually helping anyone, some of her critics want India's government to shut her down.

(On camera): If there is a clinic --

TANDON: Yes.

GRIFFIN: In Delhi.

TANDON: Yes.

GRIFFIN: That is injecting what are claimed to be human embryonic stem cells and promising that -- or at least saying that this will make you better, is that something that the Indian government should pay attention to?

TANDON: Well, the answer is a very strong yes.

GRIFFIN (voice-over): Moreover, he says, clinics like the one operated by Dr. Shroff, who cater especially to paraplegic patients, are worthless.

(On camera): Is there stem cell treatment proven in India that will make them better?

TANDON: Well, I'll answer this question even in a stronger term. Not only proven in India, but not proven anywhere in the world.

GRIFFIN: The answer is no?

TANDON: The answer is no.

GRIFFIN: When I hear --

SHROFF: Yes, OK.

GRIFFIN: -- a secretary from the Ministry of Health tell me that this experimental therapy is unproven, that so far we have no idea if it works, that we need more regulations to prevent Wild West type of medical procedures going on at clinics --

SHROFF: Yes.

GRIFFIN: Like yours.

SHROFF: Yes.

GRIFFIN: How do I explain that you believe that what you're doing is not largely experimental.

SHROFF: You see there are actually different components here. Number one, the regulatory bodies. Number two is me and the clinics and the patients, right? That's two different bodies here. As far as I personally go, I believe that I know what I do. I believe my patients are getting better. I have proved it time and again.

GRIFFIN (voice-over): To be honest, it's hard to tell patients are improving.

UNIDENTIFIED MALE: It's gotten a lot stronger.

GRIFFIN: Even when they show you they supposedly have improved. When we left the Shroff clinic and left Cash and his mother Stephanie, he looked and acted pretty much the same as when we'd seen him months earlier back in South Carolina. Struggling at times. Alert at times.

KROLICK: I feel like the first time was definitely worth a shot. We had heard things that made us feel like there was a good chance that it could help. I still believe that we saw changes.

GRIFFIN: A month later, back home, Cash again looked and acted about the same. Stephanie Krolick was more confident the experimental treatment she told us, did work, if only in very small ways.

(On camera): Do you attribute that to the stem cell therapy.

KROLICK: I've thought about it a lot. Especially knowing you were going to ask. And yes, I do.

GRIFFIN (voice-over): Stephanie Krolick and Josh's father want to do everything they can for their son.

KROLICK: Stay with us.

GRIFFIN: He remains incurable. The stem cell treatment is over. More than $50,000 has been spent.

KROLICK: I know you're saying all kinds of things.

GRIFFIN: Whatever happened in India, certainly did not provide any miracles.

(On camera): What do you think for Cash's future? What's the optimal that you can expect?

KROLICK: I don't even have any answer is the thing, I feel like as Cash's mom, I don't hide him. We go out. We go do things. And you know, we all love him the way he is. It's one thing to be really helpless when you're 6. It's a whole different thing to be really helpless and in diapers when you're 16. Which is one of the reasons why I feel like I have to do this. Because if it gets him that much closer to being able to take care of himself, I have to do it.