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NCT05211986 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.
A Phase 1 study of Muscle Atrophy, sponsored by Immunis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 2
- Study locations
NCT05211986: Recruiting Phase 1 study of Muscle Atrophy, sponsored by Immunis.
NCT05211986 is a Phase 1 study of Muscle Atrophy that is actively recruiting participants, run by Immunis. The registered enrollment target is 28 participants, below the 47-participant average among 11 other Muscle Atrophy trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05211986, a Phase 1 study of Muscle Atrophy, is actively recruiting participants, sponsored by Immunis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 2
- Study locations
Study Summary
An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis
Primary Outcome
Determined by the incidence and severity of dose-limiting toxicities (DLTs) and the incidence of treatment-emergent adverse events (TEAEs). Adverse events (AE) are classified based on Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 0 = no adverse events, Grade 1= mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = fatal adverse events. A DLT is defined as any AE related to IMM01-STEM of a Grade 2 unresolved within 48 hours post-injection,
Conditions Studied
Interventions
- DRUG IMM01-STEM
Study Locations (2)
California
- Orthopaedic Specialty Institute - Irvine
- University of California, Irvine - Alpha Stem Cell Clinic - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT05211986 shows while recruiting
NCT05211986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 47-participant average among 11 other Muscle Atrophy trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Muscle Atrophy appearing as the primary indexed condition, and to 1 intervention - of which IMM01-STEM is the first listed.
NCT05211986 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05211986 about?
NCT05211986 is a clinical study titled "Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.". An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis
What is the current status of trial NCT05211986?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2022-09-13. Estimated completion is 2026-06-30.
What conditions does trial NCT05211986 study?
This clinical trial studies the following conditions: Muscle Atrophy.
What interventions are being tested in trial NCT05211986?
The interventions under investigation include: IMM01-STEM (DRUG).
Who is sponsoring clinical trial NCT05211986?
This trial is sponsored by Immunis, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05211986 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Muscle Atrophy
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 NCT05211986's enrollment target sits among peer trials
28 8th of 11 higher than 4 of 11 other Muscle Atrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle Atrophy 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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