Cellistem®OA is a cryopreserved, ready-to-inject, allogeneic cell therapy based on a subpopulation of umbilical cord tissue mesenchymal stem cells (UC-MSCs). This proprietary therapy possesses unique attributes that render it ideal for addressing inflammation and pain in osteoarthritis (OA).
Stem Cell Therapy for Osteoarthritis
11,000
Million USD, Global OA Therapeutics Market by 2025
8.7
CAGR for the 2020-2025 period
32.5
Million of adults OA Prevalence in the US
“I am very impressed to see what Cellistem® has achieved in so many Level 1 clinical studies, given that it has demonstrated preliminary effectiveness and very promising results in cases of mild to moderate arthritis (…) This is a very good study, which marks a reference point because it shows the long-term effects through surveys of standardized pain, such as the WOMAC quality of life survey. This shows what we knew from the theoretical point of view, that the cell therapy would have a very positive effect in this type of treatment.”
Dr. Thomas Vangsness
Orthopedic Surgeon and Associate Professor of the School of Medicine at the University of Southern California.
World’s first survey of UC-MSCs in knee osteoarthritis. Following preclinical studies, Cells for Cells’ examined the safety and efficacy of both single and repeated injections of UC-MSCs in patients with symptomatic knee OA compared with hyaluronic acid (HA). This Phase I/IIA clinical trial was the first survey of UC-MSCs in knee OA and the first trial of repeated intra-articular MSC injections. Notably, there were no serious adverse events, deaths, permanent disability, neoplasia, or septic arthritis cases. Moreover, at the end of the study’s follow-up (12 months), the group with repeated UC-MSC intra-articular injections experienced significant clinical changes in total WOMAC, pain component, and VAS compared with HA. Compared with baseline, only patients in the MSC groups experienced significant amelioration of pain and disability at 6 and 12 months of follow-up as opposed to the control HA group.
Our proprietary stem cell therapy is already being produced in the US. Cells for Cells’ patented umbilical cord tissue mesenchymal stem cells (UC-MSCs) were tech transferred to the US thanks to a collaboration with the University of Miami. Thus, batches of our Cellistem®OA produced in US soil were validated according to clinical-grade standards by an accredited third party. All batches passed the stringent QC tests required by the FDA to initiate clinical trials in the US. Cells for Cells will now compile all preclinical, clinical, and manufacturing data associated with this therapy and file an IND application to the FDA by the first months of 2023.
More than 700 patients have been treated with Cellistem®OA in South America. “When I could get down the stairs of my house and walk normally, for me, that was a miracle because it had been between a year and a year-and-a-half without adequate mobility,” said María Elena Marín, a Chilean patient treated with Cellistem®OA. Like María, more than 700 patients have seen their quality of life drastically improved by our therapy across South America. Cells for Cells has conducted clinical studies in Chile and Colombia, which has broadened accessibility to our allogeneic stem cell therapy and our network with local healthcare practitioners. These treatments are produced in Cell Therapy Lab with GMP (Good Manufacturing Practices) standards and manufacturing processes certified under ISO 9001.
