Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Cardiovascular Disease and Peripheral Arterial Disease, sponsored by Indiana University.
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 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment-related adverse events will be categorized in overlapping systems of cardiovascular, respiratory, or infectious and severities of serious adverse events (SAE) and major adverse cardiac events (MACE). The sum and difference between routes of delivery will be reported. Confidence intervals will be generated and summarize the data by the method of the Wilson Score Interval. Binomial confidence intervals at the 95% confidence level and p-values for these groups will be calculated. Continuo
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 |
What the finished NCT02685098 record still lists
NCT02685098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cardiovascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02685098's enrollment target sits among peer trials
81 86th of 137 higher than 52 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Fx-5A in Healthy Volunteers
RECRUITING · Phase 1
-
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
COMPLETED · Phase 1
-
Fructose-Induced Palmitate Synthesis in Overweight Subjects
COMPLETED · Phase 1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
COMPLETED · Phase 1
-
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
COMPLETED · Phase 1
-
Single-tracer Multiparametric PET Imaging
RECRUITING · Early Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04966481 · 81 participants · Phase 3
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor
- NCT05109429 · 81 participants · NA
Developing a Clinical Outcome Assessment for Opioid Craving
- NCT05112601 · 81 participants · Phase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
- NCT05305911 · 81 participants · Phase 2
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI