Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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 3 dose cohorts: Cohort A, IMM01-STEM 225μg; Cohort B, IMM01-STEM 450 μg; and Cohort C, IMM01-STEM 900 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05211986
Study type Interventional
Source Immunis, Inc.
Contact Joelle Hafen, BS
Phone 9496907911
Email [email protected]
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date March 2022
Completion date June 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03662555 - Effect of Neuromuscular Electrical Stimulation Combined With Blood Flow Restriction on Muscular and Cardiovascular Function N/A
Completed NCT00060970 - Evaluating Muscle Function After Ankle Surgery N/A
Completed NCT03797781 - Protein Ingestion and Skeletal Muscle Atrophy N/A
Completed NCT03299972 - Multidisciplinary Research Into the Effects of Resistance Exercise and Whey Protein Supplementation in Healthy Older Men N/A
Recruiting NCT05072652 - Short Term Immobilization of the Lower Limb N/A
Recruiting NCT05115643 - Brain and Muscle Plasticity During Immobilization N/A
Recruiting NCT04199936 - Postoperative Electrical Muscle Stimulation (POEMS) N/A
Not yet recruiting NCT04772040 - Impact of Fish Oil Dose on Tissue Content and Function N/A
Enrolling by invitation NCT04456530 - Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study Phase 2/Phase 3
Recruiting NCT03551990 - Influence of Motor Proteins on Muscle Atrophy in Cancer Patients N/A
Recruiting NCT05206253 - Effectiveness of Egg Versus Whey Protein Powder During Resistance Training N/A
Recruiting NCT04900701 - The Impact of Energy Intake and Short-term Disuse on Muscle Protein Synthesis Rates and Skeletal Muscle Mass in Middle-aged Adults. N/A
Withdrawn NCT03069781 - The Effects of 17β-estradiol on Skeletal Muscle Early Phase 1
Recruiting NCT02221804 - The Effect of Two Weeks of Voluntary Reduced Physical Activity in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT01991171 - Effectiveness of the Kinesio Taping® in Muscle Activation N/A
Active, not recruiting NCT01470950 - Characterization of the Changes in the Signalling Pathways During Spinal Cord Injury-induced Skeletal Muscle Atrophy N/A
Terminated NCT03153826 - Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of COPD N/A
Not yet recruiting NCT05314413 - Examining Sex-based Differences in Metabolic and Mechanistic Responses to Disuse Induced Muscle Atrophy N/A
Completed NCT03046095 - The Regulation of Human Skeletal Muscle Mass by Contractile Perturbation N/A
Recruiting NCT04753450 - Correlation of Muscle Ultrasound Measures (2D and 3D) With Biphotonic X-ray Absorptiometry in Oldest Old Patients.