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NCT02685098 · ClinicalTrials.gov registry record · Phase 1
A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation
A Phase 1 study of Cardiovascular Disease and Peripheral Arterial Disease, sponsored by Indiana University.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT02685098 is a Phase 1 study of Cardiovascular Disease and Peripheral Arterial Disease that has completed, run by Indiana University. The registered enrollment target is 81 participants, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02685098, a Phase 1 study of Cardiovascular Disease and Peripheral Arterial Disease, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complications after surgery and decrease the incidence of revision and further amputation. Cohort Groups 1-4 will serve as controls.
Conditions Studied
Interventions
- BIOLOGICAL Allogeneic bone marrow derived mesenchymal stem cells
Study Locations (1)
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2017-01-23 |
| Est. Completion | 2023-10-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02685098
The ClinicalTrials.gov registry entry for NCT02685098 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,713-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (97% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Allogeneic bone marrow derived mesenchymal stem cells is the first listed.
NCT02685098 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT02685098 about?
NCT02685098 is a clinical study titled "A Clinical and Histological Analysis of Mesenchymal Stem Cells in Amputation". Patients undergoing semi-elective lower extremity major amputation from complications associated with atherosclerotic limb ischemia will received intra-muscular injections of allogeneic Mesenchymal Stromal Cells in the leg above and below the point of amputation to prevent ischemic wound complicatio...
What is the current status of trial NCT02685098?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2017-01-23. Estimated completion is 2023-10-03.
What conditions does trial NCT02685098 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Peripheral Arterial Disease, Atherosclerosis, Peripheral Vascular Disease, Pathologic Processes.
What interventions are being tested in trial NCT02685098?
The interventions under investigation include: Allogeneic bone marrow derived mesenchymal stem cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02685098?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02685098 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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