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Home/Biologics/Paucity of Evidence Plagues Stem Cell Clinics
Biologics

Paucity of Evidence Plagues Stem Cell Clinics

May 31, 2018 1 min read Premium comments

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Paucity of Evidence Plagues Stem Cell Clinics
Source: Wikimedia Commons and ragesoss
Secondary#stemcells

Centers claiming to offer successful treatments for osteoarthritis (OA) of the knee are proliferating in the United States even though existing evidence fails to justify their rapid rate of growth.

The centers are claiming an 80 percent success rate in treating knee pain.

Costs to treat OA of the knee at these centers ranged from $1,150 to $12,000, with an average of $5,000 per injection, according to the investigators.

“Our role as orthopedic surgeons is to provide accurate, credible information on treatment options to our patients,” said George Muschler, M.D., Professor of Orthopaedic Surgery and Director at the Regenerative Medicine Laboratory at Cleveland Clinic. “Recent systematic reviews of cellular therapies for the treatment of knee OA (over 400 papers screened) have found poor levels of evidence for the efficacy of these treatments to date,” he said.

At present an estimated 9.9 million adults suffer from OA of the knee.

In their report at the 2018 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) the researchers detailed their contact with 317 U.S. centers that offer direct-to-consumer stem cell musculoskeletal treatments.

Sixty-five centers quoted pricing for a same-day stem cell unilateral knee injection. According to their report, “the mean cost for each therapy was $5,156, with prices varying from $1,150 to $12,000.

Fourteen centers charged less than $3,000 and 10 clinics charged more than $8,000 per injection “Since insurance does not cover stem cell treatments, total costs were born by the patients.

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As to the treatment’s effectiveness, according to the report, “36 centers provided data with the mean marketed clinical efficacy of 82.2 percent. Ten clinics claimed 90-100 percent efficacy, 15 claimed 80 to 90 percent efficacy, 10 claimed 70 to 80 percent efficacy and one claimed 55 percent.” The researchers found no correlation between treatment costs and clinical efficacy.

The study “The Stem-Cell Market for Treatment of Knee Osteoarthritis: A Patient Perspective” appeared in The Journal of Knee Surgery

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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