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IMM01-STEM for Muscle Atrophy Related to Knee Osteoarthritis

This study is testing the safety of IMM01-STEM, a product made from stem cells that contains regenerative molecules, in people with muscle weakness due to knee osteoarthritis (KOA). Researchers want to see how well IMM01-STEM is tolerated and if it causes any side effects. The study plans to enroll up to 28 participants between 50 and 75 years old who have moderate KOA and quadriceps weakness. This is an early-stage study, and its main goal is to understand the safety of IMM01-STEM. The current status of the study is unclear.

Study design
This is an open-label, dose-escalation study, meaning both you and the study team will know which dose of IMM01-STEM you receive. Up to 28 participants will be enrolled in different dose groups.
What's involved
You would receive IMM01-STEM injections twice a week for 4 weeks, for a total of 8 injections. You will also have screening assessments before treatment and follow-up assessments.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first day of treatment up to 28 days after.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05211986

Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.

Completed
PHASE1Ages 50–75InterventionalTreatment
Immunis, Inc.
~13 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:IMM01-STEM

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of IMMUNA(IMM01-STEM) treatment in study participants with muscle atrophy related to KOA
Measured over Day 0 to Day 28

Conditions

Muscle Atrophy

Explore related trials

Muscle AtrophyOsteoarthritis of knee

NCT05211986

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Orthopaedic Specialty Institute

    Irvine, Californiano site contact published

  • University of California, Irvine - Alpha Stem Cell Clinic

    Orange, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tom Lane, PhD · STUDY_DIRECTOR · Chief Science Officer at Immunis, Inc.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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:
Female has a negative pregnancy test result at screening and prior to investigational medicinal product (IMP) administration
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Willing and able to comply with all study requirements, according to the judgment of the Investigator
Has discontinued systemic oral or intravenous steroid use for 6 months prior to Screening
Has vital sign measurements within the following ranges at Baseline (predose at Visit 2): heart rate \>50 and \<100 bpm, systolic blood pressure \>100 and \<170 mmHg, diastolic blood pressure \>50 and \<90 mmHg, and blood oxygenation (by pulse-oximetry) \>95%
Participant has undergone and failed at least 1 3-month or longer treatment regimen (ie, activity modification, weight loss, physical therapy, anti-inflammatory medications, or injection therapy) within a 2-year period prior to the Screening visit.
Study participant is able to speak, read, and understand English, in order to understand the nature of this study.

Exclusion

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)
Participant has had a change in medication to manage comorbid condition(s) (including diabestes, hypertension, asthma, and cardiovascular disease) within 1 month of the Screening visit.
Participant received intra-articular cortisone or viscosupplementation product(eg, Synvisc®) injections within 3 months prior to the first dose of IMP.
Has had administration of a live, attenuated vaccine within 28 days of starting study treatment or anticipation that such vaccine will be required during the study Prior/concurrent clinical study experience
Has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
This criteria was deleted with protocol amendment 6
This criteria was deleted with protocol amendment 6
This criteria was deleted with protocol amendment 6
Has current or past history (10y) of smoking
Has a history of chronic alcohol or drug abuse within the previous 3 months
Participant is currently using a systemic oral or intravenous steroid regimen (eg, for asthma or other chronic respiratory condition) or brief course of systemic pulse steroid administration (eg, for flare up of nonarthritic condition or COVID-19).

What this trial measures

  • Safety of IMMUNA(IMM01-STEM) treatment in study participants with muscle atrophy related to KOADay 0 to Day 28

    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.