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Expanded autologous ASCs · 1 trial · 2 indications
To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. \[ Designated as safety issue: Yes \]
| Arm | Type | Description |
|---|---|---|
| Autologous ASCs | OTHER | Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells. |
| Name | Type | Description |
|---|---|---|
| Expanded autologous ASCs | BIOLOGICAL | Drug: Expanded autologous adipose-derived adult stroma/stem cells |
Inclusion Criteria: * Severe peripheral vascular disease not amenable to bypass or angioplasty * Age \>40 years old * Normal renal function (creatinine \< 1.6) * Non pregnant female * Lifespan \> 6 months Exclusion Criteria: * Age \<40 years old * Refusal to give informed consent and/orCognitivel...
Expanded autologous ASCs is an investigational cell therapy being studied for peripheral vascular diseases, including cardiovascular diseases. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
Expanded autologous ASCs is being developed by Establishment Labs Holdings Inc., a company traded on the stock exchange under the ticker symbol ESTA. The therapy is currently in Phase 1 clinical trials.
Expanded autologous ASCs is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved for commercial use. One Phase 1 trial has been completed.
Expanded autologous ASCs has been studied in one completed Phase 1 clinical trial, identified as NCT01211028. This trial, titled 'Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine', enrolled 13 participants with peripheral vascular diseases and cardiovascular diseases in France.
Expanded autologous ASCs refers to a specific cell therapy product derived from a patient's own adipose tissue. The clinical trial NCT01211028 investigated this therapy for peripheral vascular diseases. The term 'ASC' commonly stands for adipose-derived stem cells, and this product is expanded from autologous sources.