Stemchymal® Product Safety
As a therapeutic biologic for allogeneic use, Stemchymal® has demonstrated evidence of safety from numerous preclinical studies and initial clinical research:
- Long-term genetic consistency— Stemchymal® can be ex vivo long-term cultured without genetic abnormality.
- No tumorigenesis observed — Animal test proven.
- Low immunogenicity —In vivo examinations have shown that Stemchymal® will not elicit inflammatory reaction. No human leukocyte antigen matching is required before administration.
- Clinical evidence of safety — No safety issues with Stemchymal® were observed in the initial Phase I clinical trial.
