Safety of Adipose-Derived Stem Cell Stromal Vascular Fraction
Summary
A single-arm, open-labeled, single-center, descriptive and exploratory safety trial using ADSC-SVF-002. ADSC-SVF-002 is an autologous adipose derived stem cell (ADSC)-containing stromal vascular fraction (SVF) obtained from subcutaneous fat harvested by liposuction from a patient. As a cellular therapy product, ADSC-SVF-002 (fresh or cryopreserved) will be administered subcutaneously via injection, with or without unprocessed autologous fat (fresh or cryopreserved), into soft tissue defects and abnormally healing wounds. The primary objective of the trial is to demonstrate the safety of ADSC-SVF-002 in a population of subjects with soft tissue defects or abnormal wound healing who are still symptomatic despite being managed by conventional therapies.
Timeline
- Start
- 2017-10
- Primary completion
- 2020-10
- Completion
- 2021-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADSC-SVF-002 | Cell therapy | 1e+06 unknown | Subcutaneous |
| Subject | ADSC-SVF-002 | Cell therapy | 1.2e+06 unknown | Subcutaneous |
Indications
No indication recorded.