NCT05211986

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Immunis, Inc. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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

Detailed description

This will be an open-label, dose escalation study to assess the safety and tolerability of IMM01-STEM, a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules, in participants with muscle atrophy related to knee osteoarthritis (KOA). Up to 18 participants will receive twice weekly intramuscular administration of IMM01-STEM for 4 weeks in up to 4 dose cohorts: Cohort A, IMM01-STEM 225μg; Cohort B, IMM01-STEM 450 μg; and Cohort C, IMM01-STEM 900 μg; Cohort D, IMM01-STEM 2000 μg. Study participants will sign a written Informed Consent Form (ICF) prior to the conduct of any study related procedures. A study participant who provides written informed consent will be screened within 28 days prior to treatment. Screening assessments will be conducted, after which the study participants' eligibility will be determined on the basis of the inclusion and exclusion criteria. Eligible participants will be enrolled and undergo Baseline assessments on Day 1. Patients will receive IMM01-STEM twice a week for 4 weeks, for a total of 8 injections. Site staff will administer study medication by im injection using a small-gauge needle (eg, 24 or 26 Ga) at all scheduled visits. After each administration of study medication, participants will be observed for 3 hours to monitor for injection-related reactions and other early onset treatment-related adverse events (AEs), in particular for the presence of allergic reactions. After Visit 2 and 3, there will be follow-up phone contact 6 to 8 hours later the same day and once the day following each injection. After their last injection, participants will enter a Safety Follow-Up (SFU) period, with clinic visits 3 days after their last injection and then monthly for 3 months.

Conditions

• Muscle Atrophy

Interventions

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

Timeline

• Start date: 2022-09-13
• Primary completion: 2026-03-30
• Completion: 2026-06-30
• First posted: 2022-01-27
• Last updated: 2025-10-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study