RecruitingMuscle Atrophy
Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.
Eligible age
50–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis
Sponsor: Immunis, Inc.
You may qualify if…
- ✓ Has moderate KOA (defined as Kellgren-Lawrence \[KL\] grade 2 to 3) on affected limb
- ✓ Has quadriceps weakness (\<7.5N/kg)
- ✓ Can ambulate \>50 feet unassisted
- ✓ This criteria deleted with protocol amendment 6
- ✓ Has a body mass index (BMI) of \<40kg/m2
- ✓ A male must agree to use contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
- ✓ A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- ✓ 1. Not a woman of childbearing potential (WOCBP). OR
You may not qualify if…
- ✕ Severe KOA (defined as KL grade \>3) on contralateral limb
- ✕ Has had prior total knee arthroplasty
- ✕ Has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol
- ✕ Has current or past history of malignancy (5y) excluding nonmelanoma skin cancer
- ✕ Has neurological, vascular, or cardiac condition that limit function, or, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- ✕ Has uncontrolled comorbidities including diabetes (hemoglobin A1c level \>7.0%), Hypertension (resting heart rate \>100 bpm, systolic blood pressure \>170 mmHg, or diastolic blood pressure \>90 mmHg), cardiovascular disease, asthma, or COPD.
- ✕ Is known positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) or human immunodeficiency virus-1/2 antibody (HIV-1/2Ab). Patients with a negative RNA test for HCV are acceptable.
- ✕ Is taking a prohibited medication or has taken a prohibited medication (narcotic pain medication, local anti-inflammatory, other investigational drugs)
Where it's recruiting
California
Irvine · Orange
Source: ClinicalTrials.gov · NCT05211986 · last updated 2025-10-30