AlloJoin by CBMG Becomes China's First Stem Cell Therapy Approved for Phase II Clinical Trial

Recently, Cellular Biomedicine Group, located in Zhangjiang Science City, announced that its allogeneic human adipose-derived mesenchymal progenitor cell injection, AlloJoin, for the treatment of knee osteoarthritis (KOA), has received the "Drug Clinical Trial Approval" (Approval No. CXSL1800109) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. Notably, this marks the first stem cell therapy product clinical trial approved under the CDE’s implicit permission system, directly entering Phase II clinical trials. It is also the first Phase II clinical trial for a stem cell product approved since the release of the "Technical Guidelines for Research and Evaluation of Cell Therapy Products."

It is understood that current conventional treatments for osteoarthritis patients in China include oral administration of anti-inflammatory analgesics and glucosamine-containing medications, intra-articular injections of sodium hyaluronate, physical therapy, and surgical interventions.

The American Academy of Orthopaedic Surgeons (AAOS) guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs) as the sole pharmacological treatment for osteoarthritis (“Treatment of Osteoarthritis of the Knee: Evidence-Based Guideline,” AAOS, 2013). However, these agents cannot delay articular cartilage wear or the progression of osteoarthritis. Consequently, there is currently no effective intervention to prevent the progression of arthritis, highlighting an urgent need for novel therapeutic approaches.

Cellular Biomedicine Group’s stem cell technology platform covers the development of products for degenerative diseases such as knee osteoarthritis and cartilage injury. The “off-the-shelf” allogeneic stem cell technology AlloJoin®, which recently received implicit approval for clinical trials, is derived from Cellular Biomedicine Group’s mature cell technology platform and clinical research data on autologous adipose-derived mesenchymal progenitor cells (ReJoin®) for the treatment of knee osteoarthritis.

In addition to confirming the safety and efficacy of autologous adipose-derived mesenchymal progenitor cells in the treatment of knee osteoarthritis through previous ReJoin® clinical trials, the Phase I clinical trial of AlloJoin® also established the safety of allogeneic adipose-derived mesenchymal progenitor cells. Furthermore, animal studies conducted by Cellular Biomedicine Group (Shanghai) Ltd provided preliminary evidence supporting the efficacy of allogeneic adipose-derived mesenchymal progenitor cells in treating knee osteoarthritis.

Meanwhile, the early-phase clinical safety study of AlloJoin® was supported by the National Health Commission, the Shanghai Municipal Health Commission, and Shanghai Jiao Tong UniversityMedicinewith the strong support, rigorous ethical review, and quality oversight of Renji Hospital, affiliated with the university.

Furthermore, AlloJoin has secured 37 Chinese patents, 3 international PCT patents, and 5 proprietary technologies, covering its entire CMC process. This encompasses adipose tissue collection, transportation, and storage; quality control methods; isolation and purification of adipose-derived stem/progenitor cells; large-scale clinical-grade cell production; as well as formulation and preparation.

Regarding the approval of Cellular Biomedicine Group’s AlloJoin for Phase II clinical trials, industry experts stated that “off-the-shelf” allogeneic stem cell products derived from haMPC donor libraries offer greater clinical benefits to patients and physicians by accelerating production processes, facilitating clinical application, and reducing treatment costs. A single standardized manufacturing process can meet the needs of a larger patient population.