Evaluation of Safety, Tolerability, and Efficacy of CordSTEM-DD in Patients With Chronic Low Back Pain

Summary

The purpose of this clinical study is to evaluate the safety, tolerability, and efficacy of CordSTEM-DD, an allogeneic umbilical cord-derived mesenchymal stem cell, as a cell-therapeutic drug in patients with chronic low back pain due to lumbar intervertebral disc degeneration.

Timeline

Start

2020-09-21

Primary completion

2023-04-17

Completion

2023-04-17

Outcome

Met primary endpoint

release “결과보고서에 따르면 1차 지표인 안전성 평가에서 용량제한 독성(Dose Limiting Toxicity, DLT)이 확인되지 않았고, 임상시험의약품과 관련한 Grade 4,5의 중대한 이상약물반응이 보고되지 않아 안전성과 내약성이 확인됐다.” chabio.com ↗

Drugs

Indications