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Home/Biologics/India Firm Gets Stem Cell Treatment Approved
Biologics

India Firm Gets Stem Cell Treatment Approved

April 24, 2017 1 min read Premium comments

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India Firm Gets Stem Cell Treatment Approved
Courtesy of Regenerative Medical Services Regrow
Secondary

Mumbai-based Regenerative Medical Services Regrow (RMS Regrow) announces that it has received market authorization for India’s first cell therapy product, Chondron ACI, from Drug Controller General of India (DCGI), which works under the Central Drugs Standard Control Organization (CDSCO).

The company claims that Chondron ACI is indicated for treatment of cartilage defects of the joints. It uses the body’s own autologous cartilage cells which are cultured and multiplied for 3-4 weeks at Regrow’s cell processing center. The cultured cells are then implanted into the patient’s damaged joint leading to new cartilage regeneration and in this way, avoiding the need of early joint replacement.

“We are immensely happy with the [India Regulators] approval for Chondron ACI. We are the first in the country and fourth in the world to achieve this approval. We are creating new age cartilage regeneration procedure which optimizes the chances of healing due to the use of the body’s own cells,” commented Yash Sanghavi, chief executive officer & managing director, RMS Regrow.

“In India, osteoarthritis is the most prevalent form of arthritis, affecting over 15 million adults every year, with the number likely to escalate to over 60 million by 2025. There is no specific treatment proven as yet that can reverse the joint damage caused by osteoarthritis. Hence the objectives of osteoarthritis management are to reduce the level of pain, reduce inflammation, slow cartilage degradation, improve function and reduce disability.”

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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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