India's first off-the-shelf cell therapy treatment for knee osteoarthritis

One injection will cost Rs 1.25 lakh with effects lasting for two years or more

Alkem Laboratories (Alkem) and Stempeutics, a Bengaluru-based biotechnology company, are launching the first ‘off-the-shelf’ stem cell therapy - StemOne - for treating patients with osteoarthritis (OA).

Priced at Rs 1.25 lakh for a single injection, the effects can last up to two years or more in a patient progressively seeing wear and tear of the cartilage in the knee.

Alkem and Stempeutics claimed this is the first ‘allogeneic cell therapy’ product to be approved for commercial use in knee OA.

Cell therapies are typically autologous. The stem cells come from the same person who gets the transplant - meaning the patient is his/her own donor. These customised therapies take time, are more expensive, and used in cancer therapy. For example, stem cell cancer treatment in the US costs nearly Rs 1 crore.

In allogeneic transplants, stem cells are not from the patient. This makes this product off-the-shelf. Stempeutics, a group company of Manipal Education and Medical Group, developed this product over 12 years.

The company’s proprietary technology ensures more than 1 million doses can be produced from a single set of master cell banks. This makes product manufacturing scalable, and it can be made available to patients at an affordable price point.

Around 35 million people suffer from knee OA in India. The current treatment options include non-steroidal anti-inflammatory drugs, hyaluronic acid injections, steroid injections, etc.

Manohar B N, managing director and chief executive officer, Stempeutics, said existing treatment options focus on providing temporary pain relief and reducing inflammation during early stages without affecting the course of the disease.

In contrast, StemOne not only reduces pain, but also has the potential to maintain cartilage quality and stall disease progression in Grade 2 and 3 OA patients. It also reduces inflammation in the knee joint, and may initiate the repair process as well.

“We believe StemOne is a game-changer, offering advanced therapeutic treatment to millions of patients suffering from this painful condition,” said Manohar.

Alkem has partnered Stempeutics to market the product. They also funded the clinical trials of this product. At present, Stempeutics will be manufacturing the product for Alkem to market and distribute it. Manohar added they were in talks with Bengaluru-based Kemwell Biopharma for contract manufacturing of the product.

Sunil Pathak, senior vice-president and cluster head at Alkem, said, “Knee OA is a serious and painful condition that impacts patients worldwide. We are happy to be able to introduce this stem cell therapy in the country at an affordable cost. Current knee OA treatments are more symptomatic in nature, whereas StemOne drug has the potential to address the root cause of the disease.”

OA is a common and debilitating chronic degenerative disease afflicting the larger joints, especially the hip and knee, characterised by loss of articular cartilage.

Worldwide, approximately 9.6 per cent of men and 18 per cent of women aged over 60 have symptomatic OA.

‘JOINT’ EFFORT

• Drugs Controller General of India approved first StemOne for treating knee osteoarthritis (OA)
• First Made-in-India cell therapy product for OA
• OA affects 35 million people in India
• No disease modifying drugs options available for OA
• StemOne injection is an outpatient procedure
• Price is Rs 1.25 lakh for an injection, with effects lasting for up to two years
• 200,000 knee transplant surgeries happen every year in India