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NCT02805023 · ClinicalTrials.gov registry record · Phase 1
BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)
A Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Disease, sponsored by BioGenCell.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 5
- Study locations
NCT02805023: Active Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Disease, sponsored by BioGenCell.
NCT02805023 is a Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Disease that is active but no longer recruiting, run by BioGenCell. The registered enrollment target is 40 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02805023, a Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Disease, is active but no longer recruiting, sponsored by BioGenCell.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 5
- Study locations
Study Summary
Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the treatment of patients suffering from peripheral arterial disease (PAD) with critical limb ischemia (CLI) who have not responded to optimal pharmacological treatment or control of risk factors and/or had a revascularization failure, and do not have the option of further revascularization treatment.
Primary Outcome
* Incidence and proportion of incidence between treatment arms of adverse events of specific interest (AESI) and injection-related AE * Incidence of serious adverse events (SAEs) including SAEs related or probably related to the treatment * Vital signs, physical examination, and electrocardiogram (ECG) * Safety laboratory values of hematology, blood chemistry, and urinalysis * Local tolerability (injection site reaction)
Conditions Studied
Interventions
- BIOLOGICAL BGC101 (autologous EnEPC preparation)
- BIOLOGICAL Control medium
Study Locations (5)
Other
- Rambam Health Care Campus - Haifa
- Laniado Hospital - Netanya
California
- University of San Francisco - San Francisco
Connecticut
- Yale University School of Medicine - New Haven
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-06 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What the registry record for NCT02805023 still lists
NCT02805023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which BGC101 (autologous EnEPC preparation) is the first listed.
NCT02805023 lists 5 locations in 4 states (Other, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02805023 about?
NCT02805023 is a clinical study titled "BGC101 (EnEPC) Autologous Cell Therapy From Patient's Own Blood for Treatment of Critical Limb Ischemia (CLI)". Evaluate the feasibility of an autologous cell preparation composed of a mixture of cells enriched for endothelial progenitor cells (EnEPCs) and multipotent adult hematopoietic stem/progenitor cells (HSPC) (BGC101), in the treatment of patients suffering from peripheral arterial disease (PAD) with c...
What is the current status of trial NCT02805023?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2016-06. Estimated completion is 2027-12.
What conditions does trial NCT02805023 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Peripheral Vascular Disease, Chronic Limb-Threatening Ischemia.
What interventions are being tested in trial NCT02805023?
The interventions under investigation include: BGC101 (autologous EnEPC preparation) (BIOLOGICAL), Control medium (BIOLOGICAL).
Who is sponsoring clinical trial NCT02805023?
This trial is sponsored by BioGenCell, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02805023 being conducted?
This trial has 5 study locations across California, Connecticut, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02805023's enrollment target sits among peer trials
40 54th of 79 higher than 24 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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