Safety and Efficacy of Autologous Endothelial Progenitor Cell CD 133 for Therapeutic Angiogenesis (PROGENITOR)
Safety and Efficacy of Transendocardial Injection of Autologous Endothelial Progenitor Cell CD 133 for Therapeutics Angiogenesis
Sponsor: Fundación Mutua Madrileña
A PHASE1/PHASE2 clinical study on Coronary Artery Disease and Refractory Angina, this trial is completed. The trial is conducted by Fundación Mutua Madrileña and has accumulated 5 data snapshots since 2008. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.
Study Description(click to expand)The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic zones by SPECT but without any option for revascularization. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+cells. All patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. CD133+ cells were selected with CliniMacs system and were injected transendocardially guided by the NOGA XP system.
The PROGENITOR trial is a randomized, double-blinded, multicenter controlled trial including patients with Canadian cardiovascular society angina classification (CCS): II-IV and ischemic zones by SPECT but without any option for revascularization. Primary endpoint was to assess the safety and feasibility of transendocardial injection of selected CD133+cells. All patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. CD133+ cells were selected with CliniMacs system and were injected transendocardially guided by the NOGA XP system.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
-
Jan 2017 — Jun 2018 [monthly]
Completed PHASE1_PHASE2
First recorded
May 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Fundación Mutua Madrileña
- Pilar Jimenez Quevedo
For direct contact, visit the study record on ClinicalTrials.gov .