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NCT02866721 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis
A Phase 1 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02866721: Completed Phase 1 study, sponsored by University Hospitals Cleveland Medical Center.
NCT02866721 is a Phase 1 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02866721, a Phase 1 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study is being done to test if it is safe to give stem cells to adult patients with Cystic Fibrosis (CF). The kind of stem cells we are studying are called allogeneic human mesenchymal stem cells or MSCs. MSCs are cells in the body that can grow into different types of cells and respond to various environmental situations. Allogeneic means the cells come from another person (a donor). This study is only looking at whether or not it is safe to give the stem cells to adults with CF and how the infusion is tolerated. In the future, other studies may be done to see if stem cells can be a new therapeutic treatment for CF. Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require approval from the U.S. Food and Drug Administration (FDA) before they can be marketed. The FDA has not approved any stem cell-based products for usual medical care, other than some specific blood forming stem cells for certain indications.
Primary Outcome
For this study, dose limiting toxicities included the emergence of infusion-related allergic adverse events as well as regimen related toxicities in the first 24 hours after hMSC infusion of a grade ≥ 3 as scored according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. This is the number of participants who experienced a dose limiting toxicity during the study.
Interventions
- BIOLOGICAL Mesenchymal Stem Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-08 |
| Est. Completion | 2020-08 |
| Phase | Phase 1 |
What the finished NCT02866721 record still lists
NCT02866721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Mesenchymal Stem Cells is the first listed.
NCT02866721 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02866721 about?
NCT02866721 is a clinical study titled "Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis". This study is being done to test if it is safe to give stem cells to adult patients with Cystic Fibrosis (CF). The kind of stem cells we are studying are called allogeneic human mesenchymal stem cells or MSCs. MSCs are cells in the body that can grow into different types of cells and respond to vari...
What is the current status of trial NCT02866721?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-08. Estimated completion is 2020-08.
What interventions are being tested in trial NCT02866721?
The interventions under investigation include: Mesenchymal Stem Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02866721?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02866721's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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