Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.

Part of paid clinical trials in Irvine, California.

Sponsor
Immunis, Inc.
Study ID
NCT05211986
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Muscle Atrophy

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • IMM01-STEM — DRUG
    IMM01-STEM is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules.

Study Details

An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis

Key Dates

Start date
Sep 13, 2022
Status verified
Oct 2025
Primary completion
Mar 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort A
    Participants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 225μg.
  • Active Comparator: Cohort B
    Participants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 450μg.
  • Active Comparator: Cohort C
    Participants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 900μg.
  • Active Comparator: Cohort D
    Participants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 2000μg.

Primary Outcome Measure

Safety of IMMUNA(IMM01-STEM) treatment in study participants with muscle atrophy related to KOA [ Time Frame: Day 0 to Day 28 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Orthopaedic Specialty InstituteIrvineCalifornia92618
Kalyn Smith
[email protected]
949-526-1570
Adam Rivadeneyra, MD (PRINCIPAL_INVESTIGATOR)
University of California, Irvine - Alpha Stem Cell ClinicOrangeCalifornia92868-

Find similar trials in Irvine, CA

By research site
Orthopaedic Specialty Institute· Irvine, CAUniversity of California, Irvine - Alpha Stem Cell Clinic· Orange, CA

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