Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.
ConditionMuscle Atrophy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-75
SponsorImmunis, Inc.
About this trial
An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- IMM01-STEM
Treatment groups
28 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov