 "Regenerative Medical Services receives DCGI nod for cell therapy product")
The Mumbai-based Regenerative Medical Services Regrow (RMS Regrow) has received market authorisation 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).
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 centre. The cultured cells are then implanted into the patient's damaged joint leading to new cartilage regeneration, avoiding the need of early joint replacement.
“We are immensely happy with the FDA approval for Chondron ACI. We are the first in the country and fourth in the world to achieve this FDA 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 oteoarthritis management are to reduce the level of pain, reduce inflammation, slow cartilage degradation, improve function and reduce disability.
There are about 4-5 lakhs of knee, ankle, shoulder and hip replacement revision surgeries being performed in India annually and the number is only going up every year. An artificial knee will only last about a decade before wearing out.
“Knee implants are expensive and the recovery of the cartilage is not fast. Chondron ACI has 97 percent success rate with fast recovery, as observed in over 4-5 lakh cases performed worldwide. RMS Regrow is proud to announce the FDA approval for Chondron ACI and it is proprietary and patented by RMS Regrow,” said Satyen Sanghavi, chief scientific officer & executive director, Regenerative Medical Services Regrow.
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