Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced that results from the double blind, randomized, placebo-controlled phase 2 trial of its proprietary allogeneic, cultured, pooled, Mesenchymal Stromal Cell product “Stempeucel”, in patients with osteoarthritis of the knee joint have been published in the current issue of the peer-reviewed indexed journal Arthritis Research & Therapy, UK.

The paper, entitled ‘Efficacy and safety of adult human bone marro- derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel): preclinical and clinical trial in osteoarthritis of the knee joint” concluded that a single intra articular injection of Stempeucel was well tolerated and had positive effects on long term pain reduction and overall improvement in WOMAC scores which measures pain, stiffness and physical function of the patient.

In vitro studies demonstrated that Stempeucel could differentiate into chondrocytes and synthesize a significant amount of sulfated glycosaminoglycan (sGAG). In the preclinical model of OA, Stempeucel reduced pain significantly and also repaired / regenerated damaged articular cartilage in rats. In the clinical study, intra-articular administration of Stempeucel was safe, and a trend towards improvement was seen in the 25-million-cell dose group in all the pain parameters (VAS, ICOAP, and WOMAC-OA scores).

The whole-organ magnetic resonance imaging score of the knee did not reveal any deterioration of cartilage. A total of 60 patients were recruited and the study was conducted by orthopaedic surgeons across 5 hospitals i.e. MS Ramaih Medical College & Hospitals, Bengaluru; Kasturba Medical College and Hospital, Manipal; Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow; Jahangir Clinical Development Center, Jehangir Hospital, Pune and Seth G. S. Medical College and KEM Hospital, Mumbai.

Commenting on the publication of OA study paper, Dr Vivek Pandey, Associate Professor, Department of Orthopaedics, KMC & Hospital, Manipal University said: “The efficacy signal observed with respect to long term pain reduction is exciting, especially given that this trial was not powered to show statistical significance. Patients receiving a single injection of 25 cells dose of Stempeucel were safe and showed excellent pain reduction even at two-year time point. However, it would be exciting to know how these knees would respond in long term which hopefully should have positive effect. I hope that this very promising investigational therapy will be advanced to rigorous phase 3 clinical trials to test the hypothesis of cartilage repair as soon as possible.”

Lead author of the publication Dr Pawan Gupta, Vice President, Stempeutics Research said: “Current OA treatments are more symptomatic in nature whereas Stempeucel drug may address the root cause of the disease. Pre-clinical and clinical data showed that Stempeucel product is a good therapeutic option for OA patients. In phase 3 trial we are going to administer Stempeucel using ultrasound guidance and use new MRI techniques called T2 mapping to assess the quality of articular cartilage and also to assess the quantitative analyses of articular cartilage. We arelooking for a business partner to co-develop Stempeucel for OA treatment”
 
Stempeutics is an advanced clinical stage Biotech Company based out of Bengaluru. It was founded by Manipal Education and Medical Group (MEMG) in 2006 and later entered into a strategic alliance with Cipla in 2009.

Manipal Education and Medical Group (MEMG) is one of the leaders in the country, in the field of education and healthcare services, with a global footprint.