Actively Recruiting
Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.
Led by Immunis, Inc. · Updated on 2025-10-30
28
Participants Needed
2
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis
CONDITIONS
Official Title
Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has moderate knee osteoarthritis (Kellgren-Lawrence grade 2 to 3) on the affected limb
- Has quadriceps muscle weakness (less than 7.5 N/kg)
- Can walk more than 50 feet without assistance
- Has a body mass index (BMI) less than 40 kg/m2
- Male participants agree to use contraception during treatment and for at least 3 months after last dose, and avoid sperm donation during this time
- Female participants are not pregnant, not breastfeeding, and either not of childbearing potential or agree to use contraception during treatment and for at least 3 months after last dose
- Female participants have a negative pregnancy test at screening and before treatment
- Able to provide signed informed consent and comply with study requirements
- Willing and able to follow all study procedures
- Has stopped systemic oral or intravenous steroid use for at least 6 months before screening
- Has vital signs within specified ranges at baseline: heart rate 51-99 bpm, systolic blood pressure 101-169 mmHg, diastolic blood pressure 51-89 mmHg, blood oxygenation over 95%
- Has tried and failed at least one 3-month or longer treatment within 2 years before screening (such as activity modification, weight loss, physical therapy, anti-inflammatory meds, or injections)
- Can speak, read, and understand English
You will not qualify if you...
- Has severe knee osteoarthritis (Kellgren-Lawrence grade above 3) on the opposite limb
- Has had prior total knee replacement surgery
- Known allergy to the study medication or related drugs/devices
- Current or past malignancy within 5 years (except nonmelanoma skin cancer)
- Neurological, vascular, or cardiac conditions limiting function or ability to participate
- Uncontrolled comorbidities including diabetes (HbA1c over 7.0%), hypertension (heart rate over 100 bpm, systolic BP over 170 mmHg, diastolic BP over 90 mmHg), cardiovascular disease, asthma, or COPD
- Positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibodies (negative RNA test for hepatitis C acceptable)
- Taking or recently taken prohibited medications (narcotic pain meds, local anti-inflammatories, other investigational drugs)
- Changed medication for comorbid conditions within 1 month before screening
- Received intra-articular cortisone or viscosupplementation injections within 3 months before first dose
- Received live attenuated vaccine within 28 days before starting treatment or expected during study
- Current or chronic liver disease or known liver/biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones)
- History of smoking within 10 years
- History of chronic alcohol or drug abuse within past 3 months
- Currently using systemic oral or intravenous steroids or brief pulse steroid course for chronic respiratory or other conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Orthopaedic Specialty Institute
Irvine, California, United States, 92618
Actively Recruiting
2
University of California, Irvine - Alpha Stem Cell Clinic
Orange, California, United States, 92868
Active, Not Recruiting
Research Team
J
Joelle Hafen, BS
CONTACT
E
Erin Curry, PA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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