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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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • IMM01-STEM

    Drug

    IMM01-STEM is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules.

Treatment groups

28 Participants
are divided into 4 treatment groups
Group A: Cohort AActive comparator 1 intervention
Group B: Cohort BActive comparator 1 intervention
Group C: Cohort CActive comparator 1 intervention
Group D: Cohort DActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety of IMMUNA(IMM01-STEM) treatment in study participants with muscle atrophy related to KOA

Determined by the incidence and severity of dose-limiting toxicities (DLTs) and the incidence of treatment-emergent adverse events (TEAEs). Adverse events (AE) are classified based on Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 0 = no adverse events, Grade 1= mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = fatal adverse events. A DLT is defined as any AE related to IMM01-STEM of a Grade 2 unresolved within 48 hours post-injection, or any Grade 3, 4, or 5 related to IMM01-STEM during any time of treatment or during the 48-hour, acute/subacute observation period.

Time frame
Day 0 to Day 28

Secondary outcomes

1

Safety and tolerability of IMMUNA(IMM01-STEM) after 4 weeks of treatment in study participants with muscle atrophy related to KOA

Determined by incidence, type and severity of adverse events graded according to CTCAE v5.0 and CRS revised grading system and defined by clinical relevant findings at day 28 post-treatment, or worsening of previous findings from baseline at day 28 post treatment in: self-reporting, physical examination, vital signs (body temperature, body weight, blood pressure, and heart rate), laboratory data (hematology, clinical chemistry, and urinalysis).

Time frame
Day 28
2

Functionality of the knee joint after 4 weeks of treatment with IMMUNA(IMM01-STEM) in study participants with muscle atrophy related to KOA

Determined by evaluation of participants with changes from baseline at day 28 post treatment in: muscle strength (measured by isometric knee extensor torque), physical function (measured by the 6-minute walk test), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

Time frame
Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunis, Inc.

Lead sponsor

Source ClinicalTrials.gov
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