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Is Regenexx Effective & Safe? Or is it a Scam & Illegal?

Facing FDA suit, stem cell firm goes on with illegal cure

The United States Justice Department and the Food and Drug Administration have ordered doctors from a Denver, Colorado company to stop performing an illegal mesenchymal stem cell-treatment. But physicians at its Southern California affiliate have gone ahead and announced recently that they are “licensed and trained” to perform the procedure.

The FDA has asked a federal judge to stop doctors from Regenerative Sciences Inc from performing what it calls a “Regenexx” procedure marketed as a “ breakthrough, non-surgical treatment option for people suffering moderate to severe pain from joint, tendon, ligament, or bone injury.

The procedure entails removing stem cells from a patient’s bone marrow, propagating them in a special solution, then re-injecting the cells at the site of an injury.

The ongoing federal lawsuit, filed in August 2010, takes Regenerative Sciences to task for selling an unapproved drug that hasn’t been prepared in a safe manner.

In order to introduce or deliver a drug “that is also a biological product” into interstate commerce, a valid biologic license must be in effect, says FDA’s Mary A. Malarkey in a warning letter to Dr. Christopher Centeno, Regenerative Sciences medical director on July 2008.

“Such licenses are issued only after a showing of safety and efficacy for the product’s intended use,” she writes. Malarkey is the director of the FDA’s Office of Compliance and Biologics Quality at the Center for Biologics Evaluation and Research.

Malarkey says that drugs being developed may be “distributed for clinical use in humans only if the sponsor has an investigational new drug application in effect as specified by FDA regulations (21 U.S.C. 355(i); 21 CFR Part 312),”

The drug regulator also says the sales and transport of the stem cells violates a federal law regulating prescription medications.

Stem Cell Therapy Review Journal checked the website of The Health Link Medical Center, an Oceanside clinic, and found it still advertises that its doctors are “trained and certified” by the Regenerative Sciences’ Colorado team.

For its part, the Colorado clinic lists the Oceanside facility as part of its Regenexx Procedure Network, which also includes clinics in Pennsylvania, New Jersey and New York.

Few approved treatments, some clinical studies
The FDA has not approved any stem cell treatments for orthopedic injuries. The only FDA-approved stem cell treatments involve those for leukemia patients, which are now commonly used therapies.

While promising stem cell treatments often hog the headlines, these are part of highly structured clinical studies conducted in major universities. Aimed to prove that new therapies are safe and to gather more evidence that treatments are more effective than placebos, such studies take years and cost millions of dollars.

By contrast, the mesenchymal stem cells used in the Regenexx procedure are not the subject of an approved biologics license application (BLA) or part of a clinical trial or an investigational new drug application (IND) in effect, Malarkay says in her warning letter.

No science behind Regenexx
Before the FDA filed its declaration, it asked an expert to review the studies that Regenexx physician Dr. Centeno published in scientific journals.

The Regenexx procedures did not go through the kind of rigorous testing that leads to widespread acceptance in medicine, concludes George F. Muschler, an orthopedic surgeon and professor at Ohio’s Case Western Reserve University who reviewed several case studies and a safety study by Dr. Centeno.

The studies merely reported the alleged benefits of his treatments that meant to remedy unhealed fractures and torn muscles or tendons.

Altogether, the series of studies “may be degenerating into an undisciplined and unfocused and even groping and wishful fishing expedition,” Muschler said. He also found faults with the reports’ methodology, scope and oversight.

The “cultured cell product has not been tested in a single adequate and well-controlled clinical study for any of the indications for which it is being promoted and used, he says, concluding “It is my strongly held view that (Regenerative Sciences) is exposing patients to medical risk without any reliable scientific evidence of therapeutic benefit.”

The FDA also inspected the company’s facilities and uncovered shortcomings that led it to criticized the Regenexx product as being “adulterated.”

The Regenexx lawsuit is one of the first the FDA has filed over a stem cell therapy offered within the U.S.

Meanwhile, “stem cell tourism” is a growing global illicit industry that sells hope to people suffering from Parkinson’s disease, amyotrophic lateral sclerosis, spinal cord injury, severe burns, heart disease, diabetes and other severely debilitating and disabling conditions—and puts instead puts them in danger. Most of these procedures are conducted outside the U.S., in China, Russia, the Dominican Republic, Ukraine and other countries in Europe and elsewhere.

Over the years, FDA has issued several warnings over these dangerous and illegal procedures, but it does have its supporters. Many people, especially those suffering from incurable ailments themselves and those who take care of them, are critical of the painstaking and costly process of proving medications safe and effective in America.

California clinic
On its website, Health Link, Regenerative Sciences’s California associate clinic boasted that it was the first in the state to be “licensed” to perform the Regenexx procedures.

“Their stem cell orthopedics experience is unrivaled and they are physician leaders in stem cell therapy for orthopedic injuries in terms of research presentations, publications, and academic achievements,” the website says.

So far, Regenerative Sciences doctors have agreed to stop performing the Regenexx procedure while the case is argued in court. But Andrew Ittleman, a Miami attorney who is representing Regenerative Sciences, told California Watch, a news site funded by the Center for Investigative Reporting, the FDA is suing the firm over a procedure that is not being performed in California.

Ittleman claims the FDA is concerned about the group’s process of adding a growth enhancer to increase the number of stem cells taken from a patient before re-implanting them — but this technique is not practiced by the California group, he says.

The California treatment, he argues, “has very little, if anything, to do with the procedure” that’s subject to the FDA lawsuit.

Attorneys for Dr. Centeno and his partners also say the FDA lawsuit should be stricken because the procedure constitutes the “practice of medicine.”

In legal documents reviewed by California Watch, attorneys for Regenerative Sciences say that the procedure falls under state powers because it “constitutes the practice of medicine” — and this is overseen by the medical board. Medical practice isn’t regulated by the FDA, they argue.

But according to Dan Wood, a spokesman for the California Medical Board, the use of stem cell treatments falls under the purview of the FDA.

RELATED READINGS:
Is CellTex a Scam or the Stem Cell Hope of America
Stem Cell Tourism Risks, Precautions, and Warning Signs

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6 comments

1 Linda Wolfe { 08.09.13 at 1:53 am }

I would like to hear from anyone that has had stem cell for shoulder repair… My husband needs help, but we are afraid this is a scam. Please help with any information you may have. Thank you and God Bless

2 Mona Saba { 09.13.13 at 9:09 am }

Please write me if you have tried this procedure. Thank you

3 MD Newman { 10.03.13 at 8:32 pm }

I tried the stem cell procedure for my hips twice a few years ago.
Unfortunately my hips are too far gone for any stem cell repair.
Might work for damage at an early stage.
I think the FDA is being overbearing on this. This procedure simply takes the stem cells out of my own marrow and re inserts it after adding a growth enhancer to increase the number of cells. What’s the difference between that and taking my own blood and storing it in case I need it during surgery?

4 Matthew { 10.28.13 at 9:59 am }

I found this blog about this procedure from this company and I am interested to see if there is any validation to the procedure as I cannot find a a lot of information about the company except on the net which are mostly positive reviews.

http:// ww w. fluther . com/46317/anyone-have-objective-data-on-the-effectiveness-of-the-regenexx-stem/

If anybody can share positive or negative feedback with me about direct experience with this company that would be great!

5 Mark H { 01.10.14 at 8:43 pm }

I went through the procedure in late October at thee Centeno Schultz Clinic in Broomfiled CO. They were very professional-had probably the best assessment ever from their physical therapist and a very thorough assessment of my MRI by one of their physicians. I’m rated a “fair to poor” candidate based on the MRI, phone screen. Decided to go ahead instead of getting another hip replacement. No pressure tactics-price was reasonable. The procedures went well. I’m waiting to see if there’s improvement although I was able to skate-ski over the holidays. I don’t expect too much.

6 Captain Bill Yancey { 02.09.14 at 1:49 pm }

In January 08 a orthopedic surgeon said my knee had to be replaced. I was in constant pain. In February 08 I had my first injection of mesenchymal stem cells and another injection in August of 08. In November of 08 the pain in my knee completely stopped. I recommend the surgeon from Ohio call me and take a look at my knee. Unless of course he is afraid it might reduce his income from knee replacements.
To the FDA, I have 36 million cells still frozen in Colorado that I cannot use because of your law suit. Those cells are mine and cannot be used by anyone else. Malarkay states that a license is needed to sell/use my own cells in my body. Only our government could come up with such an idiotic statement/ruling.
Finally, if this procedure works, which it did on me, how many $70 thousand dollar knee replacements would not be performed? Dr. Centeno helped me keep one orthopedic surgeon from collecting his fee.

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