An Open-label Dose Escalation Study to Assess the Safety and Tolerability of IMM01-STEM in Participants With Muscle Atrophy Related to Knee Osteoarthritis
Immunis, Inc.
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
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 Consen…
Eligibility
- Age range
- 50–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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…
Interventions
- DrugIMM01-STEM
IMM01-STEM is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules.
Locations (2)
- Orthopaedic Specialty InstituteIrvine, California
- University of California, Irvine - Alpha Stem Cell ClinicOrange, California