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NCT04975841 · ClinicalTrials.gov registry record · NA
Inclusion Body Myositis Treatment With Celution Processed Adipose Derived Regenerative Cells
A NA study of Inclusion Body Myositis, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT04975841: Completed NA study of Inclusion Body Myositis, sponsored by University of Kansas Medical Center.
NCT04975841 is a NA study of Inclusion Body Myositis that has completed, run by University of Kansas Medical Center. The registered enrollment target is 9 participants, below the 235-participant average among 10 other Inclusion Body Myositis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04975841, a NA study of Inclusion Body Myositis, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, single arm study evaluating the safety for patients with Inclusion Body Myositis. A total of 9 subjects will be enrolled in the study. Subjects will be randomized to Part 1 or Part 2 of the study in blocks of 3 every 3 months. Stem cell injections will be given in the forearm and thigh on either the left or right side of the body, depending on which side meets criteria. The overall goal of this pilot study is to test the safety of adipose derived regenerative cells in patients with Inclusion Body Myositis. If determined safe, this trial could lead to larger Phase II trials. While this specific trial's primary endpoint is safety, it our ultimate hope that ADRC injections into the forearm and thigh of IBM patients will slow, stabilize, or even reverse the progression of muscle weakness in patients with IBM.
Primary Outcome
The primary endpoint of safety will be reported as counts of subjects experiencing adverse events events (including abnormal laboratory results and vital signs). Six months after the first participant is treated, safety and efficacy will be accessed in order to make a decision about whether to continue the trial. Measures of safety will be reported for the last visit observed for each participant
Conditions Studied
Interventions
- DEVICE Adipose Derived Regenerative Cells
Study Locations (1)
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-03-10 |
| Est. Completion | 2025-09-26 |
| Phase | NA |
What the finished NCT04975841 record still lists
NCT04975841 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 235-participant average among 10 other Inclusion Body Myositis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Inclusion Body Myositis appearing as the primary indexed condition, and to 1 intervention - of which Adipose Derived Regenerative Cells is the first listed.
NCT04975841 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT04975841 about?
NCT04975841 is a clinical study titled "Inclusion Body Myositis Treatment With Celution Processed Adipose Derived Regenerative Cells". This is an open-label, single arm study evaluating the safety for patients with Inclusion Body Myositis. A total of 9 subjects will be enrolled in the study. Subjects will be randomized to Part 1 or Part 2 of the study in blocks of 3 every 3 months. Stem cell injections will be given in the forearm ...
What is the current status of trial NCT04975841?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2022-03-10. Estimated completion is 2025-09-26.
What conditions does trial NCT04975841 study?
This clinical trial studies the following conditions: Inclusion Body Myositis.
What interventions are being tested in trial NCT04975841?
The interventions under investigation include: Adipose Derived Regenerative Cells (DEVICE).
Who is sponsoring clinical trial NCT04975841?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04975841 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04975841's enrollment target sits among peer trials
9 11th of 10 the lowest of 10 other Inclusion Body Myositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Inclusion Body Myositis 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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