(CNN)

Cellules souches

ont le potentiel de se diviser et de se développer en de nombreux types cellulaires différents dans le corps. Ils sont si enchanteurs et si prometteurs — ils peuvent aider les patients paralysés à reprendre l'usage de leurs membres ou aider les presque aveugles à voir — qu'ils ont des responsables de la Food and Drug Administration qui se grattent la tête.

Les autorités réfléchissent à des réglementations pour déterminer comment les cellules souches sont utilisées dans diverses procédures médicales et cosmétiques, éviter toute exploitation et préjudice aux patients, et ils ont demandé l'avis du public.

Thérapie par cellules souches

La FDA a organisé une audience publique sur le campus des National Institutes of Health à Bethesda, Maryland, la semaine dernière pour discuter des projets de documents relatifs à la régulation des cellules humaines (PDF).

Médecins, les propriétaires d'entreprise, academics and patients spoke at the two-day event and weighed in on what they think needs to change. The public can submit comments to the FDA online or in the mail by September 27.
Some are pleading for the FDA to establish merciful regulation so that sick patients can have better access to regenerative medicine. They believe stem cell therapies can help.
Others are calling for the FDA to crack down on clinics, especially those that are marketing unproven stem cell treatments. They believe some stem cell therapies can harm.

The scope of the stem cell industry

How are stem cell therapies currently regulated? The FDA has approved only one thérapie par cellules souches produit: a therapy called Hemacord that can restore low blood counts in patients with certain blood disorders.
“Cellules souches, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications,” according to the administration’s website.

Nonetheless, 570 stem cell clinics have emerged across the country, offering stem cell interventions that are not approved in the United States or don’t fit within the FDA’s regulations, according to a paper published in the journal Cell Stem Cell in June.
The researchers manually conducted an Internet search and analysis to count the number of American-based clinics.
I was surprised by the huge scope of this industry. I would have predicted half or fewer the number of clinics we found. J'ai également été frappé par l'étendue d'un océan à l'autre de cette industrie,” dit Paul Knoepfler, professeur de biologie cellulaire et d'anatomie humaine à l'Université de Californie, Davis School of Medicine et co-auteur de l'article.
“À ce jour, les régulateurs tels que la FDA n'ont pris aucune mesure significative sur les cliniques de cellules souches aux États-Unis, et on ne sait pas pourquoi. Par conséquent, les cliniques et ceux qui envisagent d'ouvrir de nouvelles cliniques voient le manque d'action comme un feu vert pour qu'ils continuent,” il a dit.
Bien que les chercheurs aient découvert des centaines de cliniques, Knoepfler a déclaré que la FDA semble n'avoir envoyé qu'une seule lettre d'avertissement à une clinique ces dernières années. Cette lettre a été envoyée à l'Irvine Traitement des cellules souches Centre en décembre.
“Ce qui semble totalement hors de proportion avec la portée de l'industrie des cliniques de cellules souches,” il a dit. “Au niveau de l'Etat, we haven’t seen state medical boards take actions as well, which also contributes to the problem.

toutefois, a wave of new studies in recent years has revealed the enticing potential of stem cell therapies, prompting some doctors and patients alike to cross their fingers that the FDA institutes more lenient and less sweeping rules.

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There are a lot of people interested in using stem cells to try to repair orthopedic problems, shooting them in the joints in the knees to try and regrow bone and cartilage. That’s been around for a while. There are lots of folks trying to use stem cells in more research settings to regrow spinal cord; there are clinical trials going on of that,” a dit le Dr. Arthur Caplan, a professor and founding head of the division of bioethics at New York University Langone Medical Center, who wasn’t involved in the FDA hearing.

Stem cells have been used to regrow gums in dentistry.

Stem cells are used in cosmetic surgery. People use them to grow fat tissue when they’re trying to reconstruct, usually for breast augmentation,” he added. “You’ll see stem cell advertisements all around.
What really turns heads, toutefois, is how some stem cell therapies have shown promise in repairing the damage caused by various diseases, such as eye diseases that cause blindness, les maladies neurodégénératives telles que la sclérose latérale amyotrophique et les maladies à médiation immunitaire telles que la sclérose en plaques.
Comme ces thérapies ne sont pas disponibles aux États-Unis, certains patients y ont accédé ailleurs.
'Nous pouvons faire mieux que cela’

C'était une expérience à l'étranger thérapie par cellules souches qui a donné à Sara Hughes, 24, nouvel espoir pour son avenir — et l'avenir de presque 300,000 d'autres patients chez qui on a diagnostiqué le même type rare d'arthrite juvénile qu'elle.
La semaine dernière, Hughes a pris la parole lors de l'audience de la FDA avec sa mère, Fiona Cunningham. La dernière fois qu'ils étaient sur le campus des National Institutes of Health, il y a quelques années, Hugues’ le corps était un squelette de 83 livres paralysé par une douleur constante.

On lui a diagnostiqué une arthrite juvénile idiopathique systémique à 11 mois et est tombée si malade à l'adolescence qu'elle a été évaluée, traité et étudié au NIH en collaboration avec ses médecins du Centre des sciences de la santé de l'Université du Texas à Houston. Hughes pouvait à peine marcher, était alité et à l'agonie, et a passé la majeure partie de sa vie à l'hôpital. Elle pensait fugitivement à l'avenir parce qu'elle ne pensait pas en avoir un.

“Sinon pour l'aide de mésenchyme autologue à haute dose thérapie par cellules souches, je ne serais pas là aujourd'hui,” Hughes a déclaré dans son discours à l'audience, ajoutant qu'elle est maintenant “en assez bonne santé” partager son témoignage.
Dans 2014, Hughes a fait cultiver ses propres cellules souches saines chez Celltex Therapeutics, une société de biotechnologie réglementée par la FDA à Houston. Une fois infusé en elle, de telles cellules pourraient aider à renforcer son corps et à normaliser son système immunitaire, qui était hyperactive en raison de sa maladie auto-immune.
toutefois, pour que les cellules saines soient réintroduites dans son corps pour traiter ses symptômes d'arthrite, Hughes a dû se rendre au Mexique. La procédure n'a pas été approuvée aux États-Unis, où elle “own stem cells are considered to be a drug,” elle a dit.

Each of her infusions had approximately 200 million stem cells in themand Hughes has received about 22 infusions over almost two years, said her mother.
I was running out of time, but I was willing to put my life at risk to get on an airplane. My quality of life had become so dismal, even one small improvement from my own stem cells would have been enough for me,” Hughes said in her speech.
What happened in the days, weeks and years following my first infusion has changed my outlook. It’s hard to believe, in my sick body, I had a wealth of healthy adult stem cells with the ability to so significantly improve my quality of life,” elle a dit. “It’s sad knowing the people who could benefit most from adult thérapie par cellules souches are probably too sick to get on an airplane. … We can do better than this.

As some people are hoping for tolerant regulation, others are calling for the FDA to take a stricter approach to stem cell therapies.
The FDA is seeking comment from all of them before official rules are established.

To be clear, what the hearing is about is feedback on guidelines that are being proposed by the FDA, and these are not binding regulations; they are just points to consider,” a dit le Dr. Insoo Hyun, associate professor of bioethics at the Case Western Reserve University School of Medicine, who did not attend the hearing.
Officially, what the regulations say is that any time a doctor puts a patient’s own stem cells back into that patient for therapy, it has to essentially be a medical bedside service. It can’t be the transfer of a product that needs FDA regulation,” il a dit. “The cells must be put back into the patient’s body, where they will perform the same basic functions as before.

A stem cell transplant can pose many

and potentially fatalrisks of complication, from infections to organ damage. A patient who underwent a thérapie par cellules souches in Florida several years ago died during the procedure, according to state authorities.
Knoepfler said he hopes that the FDA will quickly move forward tomore appropriatelyregulate the stem cell industry.
There are a number of relevant regulations that apply to stem cells. When stem cell products are significantly changed or used in a manner not consistent with their tissue of origin, the stem cells are defined as drugs and need to be approved by the FDA before they are put into patients, who are often paying tens of thousands of dollars a pop for these unproven offerings,” il a dit.
At the hearing, there was community-wide frustration in the air from both sides, said Rosario Isasi, research assistant professor in the University of Miami School of Medicine’s department of human genetics, who attended the hearing and other FDA meetings this week.
Most experts agree that the current regulatory system needs to change, but opinions on what that change should been polarizing, Isasi said of the hearing.
I think this polarization of views and interests is eroding the spirit of cooperation that has largely united the regenerative medicine community during the past two decades. This erosion of the community is an issue often missing in the debate.

The frustration was in response to three key issues, elle a dit: the slowness of the FDA to translate how clinical therapies and regenerative medicine products may be regulated, the absence of clarity on how certain products and therapies are defined in such regulation, and the time and expense to obtain regulatory approval.
Obtaining FDA approval is a long process, said Hyun, the Case Western Reserve University School of Medicine professor who did not participate in the hearing.
FDA approval comes after a series of clinical trials. So in the first phase, you want to look for safety, and then in the second phase, with a larger number of patients, you look for efficacy and whether the therapy works compared to other options, and in the third phase, it’s on a grander scale with more patients,” il a dit. “After phase three, if the data prove it’s safe and efficacious, the FDA approves it to enter the marketplace.
Seeking a ‘middle groundmarketplace

While it’s important for the FDA to focus onrogue clinicsthat are promoting unproven stem cell interventions, Isasi said, doing so shouldn’t overshadow the current FDA-approved stem cell clinical trials that are underway.
Her colleague Dr. Joshua Hare, director of the Interdisciplinary Stem Cell Institute at the University of Miami Health System, who attended the FDA hearing, agrees.
Stem cell study for ALS patients shows promise, yet causes pain
Stem cell study for ALS patients shows promise, yet causes pain
Many doctors are trying to pursue the rigorous pathway and conduct the serious clinical trials with actual stem cells ‘to move this field forward,’ ” Hare said. “Cette, toutefois, is very expensive and takes a very long time. This is why Congress is looking at ways to accelerate this. We favor a quicker pathway. We do not support cutting any corners that would compromise safety. We think there is a reasonable middle ground.
The discussions the FDA and scientific community are having about stem cell therapies are somewhat similar to the discussions that have been had about the supplement industry, said Caplan, the stem cell expert at New York University Langone Medical Center.
You might say, in a weird way, all of the supplement industry is like this. That is to say, the FDA didn’t regulate it. It grew into a gigantic industry of tens of billions of dollars. No one’s really sure what the hell works. Nobody knows what’s actually in most of the products, but people take them and use them and have all sorts of testimonials that they’ll fix everything,” il a dit. “So we’ve seen a dangerous explosion in that area. I’d say that’s somewhat like stem cells now.
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Now that the issues surrounding stem cell clinics are being discussed, Hyun said hopes that doctors and patients alikeon both sides of issuescan better understand each other.
I hope what emerges out of these discussions is much greater clarity about what the concerns are on either side and a more realistic view about where the state of stem cell research is,” Hyun said. “One thing that many people have also realized is that the idea of thérapie par cellules souches is very exciting to many people, and it gives many people hope, but it also provides the opportunity to exploit patients.
Isasi said it’s crucial to recognize that reasonable differences of opinion exist in order to move forward with establishing new regulation, which is the FDA’s end goal.
I think that common goal remains: promoting medical innovation to serve the needs of patients and the public’s health in an ethically responsible manner,” elle a dit.

thérapie par cellules souches