Sibiman officially announced the initiation of a Phase III clinical trial of AlloJoin®, an adipose-derived mesenchymal stem cell product

Recently, the biopharmaceutical company west beaman biotechnology (CellularBiomedicineGroup CBMG) officially announced, start-up company's variant anthropogenic adipose mesenchymal progenitor cells between injection AlloJoin ® phase III clinical trials. Preliminary results from a randomized, double-blind, controlled, multicentered Phase II trial (96 weeks of follow-up) indicate that AlloJion® has a favorable safety and efficacy profile in the treatment of KneeOsteoarthritis (KOA).

"We are very excited and proud to officially initiate the Phase III trial of AlloJoin® for human adipose mesenchymal Progenitor cell injection," said John Liu, Chairman and CEO of Sibiman Biotechnology. First of all, I would like to thank CDE for its recognition and support of Sibiman stem cell drug clinical trials. The formal entry of this variety into Phase III clinical trials is a great encouragement to the whole stem cell drug research and development industry in China! Over the past 10 years, Sibiman has stayed true to its original vision and continued to invest in research and development. We strive for perfection in every research and development link, hoping to ensure the safety and reliability of products through high standards and strict requirements. AlloJoin® is the first self-developed innovative stem cell drug directly entered phase II clinical with the implied approval of CDE in China. Allojoin ® is also the first stem cell drug to enter phase III clinical for knee osteoarthritis in China. It is expected to fill the gap in the field of knee osteoarthritis treatment with stem cell products in China in the future!"

AlloJoin®, Sibiman's proprietary product, has been shown to have good clinical safety in phase I and II clinical trials, as well as significantly improving knee pain stiffness and delaying knee cartilage wear in patients with KOA. The formal initiation of this Phase III trial marks another step towards addressing the unmet medical needs of 57 million KOA (KL2-3) patients in China. With the strong support and effective promotion of stem cell industry by the state and Shanghai, we believe that the future development prospect will be very broad.

About this study

The clinical study of AlloJoin® adipose mesenchymal progenitor cells in the treatment of knee osteoarthritis was initiated and carried out based on the evidence of the effect of allojoin ® adipose mesenchymal progenitor cells in the treatment of knee osteoarthritis provided by previously completed animal experiments. Meanwhile, Also derived from the mature cell technology platform and autologous adipose-derived mesenchymal progenitor cells (Re-Join®) in the treatment of knee osteoarthritis clinical data. The AlloJoin® Phase I clinical trial, completed in 2018, demonstrated a favorable safety profile for allojoin adipose mesenchymal progenitor cells. The efficacy and safety of this product was further validated in the Phase II clinical study completed in 2022. The Phase II trial results showed that AlloJoin® significantly and consistently improved knee pain and knee function in subjects, delayed articular cartilage wear, and improved patients' quality of life.