Trials / Completed
CompletedNCT02669810
EXCELLENT (EXpanded CELL ENdocardiac Transplantation)
EXpanded CELL ENdocardiac Transplantation (EXCELLENT)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- CellProthera · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected in patients with an acute myocardial infarction and a LVEF remaining below 50% versus standard of care.
Detailed description
The main purpose of this phase I/IIb is to evaluate the safety, the tolerance and the first efficacy trends of intracardiac injection of ProtheraCytes (autologous PB-CD34+ Stem Cells after automated ex-vivo expansion with the StemXpand machine) in patients with an acute myocardial infarction and decreased ejection fraction. ProtheraCytes will be reinjected using a dedicated catheter , thus avoiding open chest surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PROTHERACYTES | ProtheraCytes endocardiac injections performed with the HELIX and Morph catheters |
| DRUG | Standard Treatment for CHF post AMI |
Timeline
- Start date
- 2016-02-10
- Primary completion
- 2024-03-15
- Completion
- 2024-03-15
- First posted
- 2016-02-01
- Last updated
- 2026-03-19
Locations
13 sites across 2 countries: France, United Kingdom
Source: ClinicalTrials.gov record NCT02669810. Inclusion in this directory is not an endorsement.