Nature Cell, safety and efficacy of Vascostem for severe Buerger’s disease cases confirmed by the International Medical Society
- Results for phases 1 and 2 of clinical trials presented in Cell Medicine, an international academic journal
- Injection of patients’ own stem cells confirmed for safety and efficacy
Nature Cell announced on October 4 that the results of phases 1 and 2 of Vascostem’s clinical trials—for a stem cell-based treatment for Buerger’s disease—had been presented by international academic journal Cell Medicine.
The publication confirmed that the Biostar Stem Cell Research Institute (President Jeong-chan Ra) had cultivated stem cells extracted from Buerger’s disease patients’ fat, administered 10 million cells into 30 affected muscles in the patients, and observed them over the course of 6 months. The patients did not show any side effects or adverse reactions, confirming the safety of Vascostem.
Although there have been previous treatments available for Buerger’s disease, they have come with either restrictions or side effects (or both). However, Vascostem, with its stem cell therapy extracted from patients’ own fat, has been confirmed for its safety by the International Medical Society.
In addition, the effect of pain alleviation during periods of rest was confirmed with the Visual Analog Scale (VAS) and walking distance covered without experiencing pain was measured. For over 2 years of observation, subject patients completely abstained from or significantly reduced their intake of medicines without a single case of amputation.
Dr. Ra’s team, in cooperation with renowned guru of Buerger’s disease, Dr. Olin of the US, is currently preparing the protocols for multinational clinical trials, including in the US and Korea, and will apply to the US FDA and Ministry of Food and Drug Safety (Korea) in December of this year for a pivotal study on the treatment.
Dr. Ra said in a press conference, “We ask the Ministry of Food and Drug Safety for policy support so that we can continue our research to develop cures for rare or incurable diseases and successfully launch this treatment in the domestic market.”