First time in India: Stem cell therapy to treat knee osteoarthritis

The therapy, priced at Rs 1.25 lakh, may offer 35 million patients across the country a chance of substantially improving their quality of life without going under the scalpel.

Knee osteoarthritis is a chronic disease that affects a large number of the elderly and the obese and is characterised by degeneration of the cartilage inside the knee, which leads to pain, stiffness and tenderness.

The latest drug, which will be in the form of an intra-articular injection, can be given on an outpatient basis without the need for anaesthesia.

Stempeutics and Alkem said in a joint statement that clinical trials held in India have demonstrated significant improvement in pain relief and physical functions, as well as indicators towards decreased progression of the disease and improvements in joint structure.

The allogeneic or off-the-shelf drug could provide an alternative to traditional treatment and surgery or delay the progression of knee osteoarthritis to minimise the need for multiple surgical interventions, it added.

Benefits over traditional treatment

While conventional treatments such as physiotherapy or drugs offer temporary relief from the clinical symptoms of knee osteoarthritis, restoration of normal cartilage function has been difficult to achieve, and in extreme cases, a total knee replacement may be required, said BN Manohar, managing director of Stempeutics, in an interaction with Moneycontrol.

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Currently, treatment options available include NSAIDs, glucosamine & chondroitin sulphate, Diacerin (IL-1 inhibitor), Hyaluronic Acid injections, steroid injections, PRP injections and, ultimately, total knee replacement.

But total knee replacements are expensive and may not always be successful. In such a situation, stem cell therapy has emerged as a ray of hope over traditional approaches aimed at restoration of cartilage function in the knee, said Manohar.

It is estimated that Rs 4,000 crore is spent annually on total knee replacement surgeries in India.

“Our product is something novel, launched for the first time in India, and one of the firsts globally,” said Manohar, adding that it took about 13-14 years to develop StemOne and get regulatory approval.

The therapy has two major benefits, explained Manohar. It reduces pain in patients, eases their day-to-day living and also maintains the cartilage, preventing further deterioration.

Manohar insisted that even though the price may be higher than other invasive therapies such as intra-articular steroids, it prevents disease progression, something that other therapies don’t.

“Total knee replacement surgery, on the other hand, for patients in whom this therapy may be indicated, costs at least Rs 2 lakh and this therapy would therefore be cost-effective for them,” he said.

Insurance and regulatory approvals

The company is now also trying to get the therapy covered by private insurance and Manohar said that since this therapy is in the category of regenerative medicine, considered a new class of therapeutics, even the regulatory process is still evolving.

The firm took around 14 years to develop and launch the product.

“One is the science part to see how the stem cell works and what it can do and what it cannot do and then we need to see the safety of this compound,” said the MD.

Manohar added that subsequently, the company carried out multiple sets of clinical trials to assess safety and efficacy and also needed to work with the drug regulators.

Since there is no proper regulatory framework to cover stem-cell based products, the manufacturer had to coordinate with the Indian Council of Medical Research on how it could be regulated. “It took some time to develop the guidelines and now stem cells are considered to be a drug,” said Manohar.

Other products

Stempeutics is the only company to have launched a stem cell therapy for Critical Limb Ischemia, a peripheral vascular disease, where blood doesn’t flow due to blockages in peripheral arteries.

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In some cases, Critical Limb Ischemia can get so bad that patients may need to have their forearms or legs amputated. The therapy for this disease was launched in partnership with Cipla.

Another new product, in the pipeline, targets non-healing diabetic foot ulcers.

“As there are no good medicines available for the condition, there is a very huge opportunity here,” said Manohar. “Our product is currently under development and it may take a year or so to assess whether it's effective,” he said.