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Muscle AtrophyPhase 1/2STEM-MYONCT05211986

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

A Phase 1/2 study testing IMM01-STEM in people with Muscle Atrophy, run by Immunis, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Atrophy
What is being tested?
IMM01-STEM
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesUnited States
Study dates
13 Sep 2022to 27 Jul 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP). OR
  • A WOCBP who agrees to follow the protocol's contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.
  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Orthopaedic Specialty Institute

    Irvine, California, 92618

  • University of California, Irvine - Alpha Stem Cell Clinic

    Orange, California, 92868

Other trials in United States

About this study

Official title: An Open-label Dose Escalation Study to Assess the Safety and Tolerability of IMM01-STEM in Participants With Muscle Atrophy Related to Knee Osteoarthritis

An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis

Read the detailed 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 Consent Form (ICF) prior to the conduct of any study related procedures. A study participant who provides written informed consent will be screened within 28 days prior to treatment. Screening assessments will be conducted, after which the study participants' eligibility will be determined on the basis of the inclusion and exclusion criteria.

Eligible participants will be enrolled and undergo Baseline assessments on Day 1. Patients will receive IMM01-STEM twice a week for 4 weeks, for a total of 8 injections. Site staff will administer study medication by im injection using a small-gauge needle (eg, 24 or 26 Ga) at all scheduled visits. After each administration of study medication, participants will be observed for 3 hours to monitor for injection-related reactions and other early onset treatment-related adverse events (AEs), in particular for the presence of allergic reactions. After Visit 2 and 3, there will be follow-up phone contact 6 to 8 hours later the same day and once the day following each injection.

After their last injection, participants will enter a Safety Follow-Up (SFU) period, with clinic visits 3 days after their last injection and then monthly for 3 months.

Conditions
Muscle Atrophy
Being tested
IMM01-STEM
Medical subject headings
Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMM01-STEMDrug

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

Study groups in NCT05211986
Study groupRoleWhat they receive
Cohort AActive comparatorParticipants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 225μg.
Receives: Drug: IMM01-STEM
Cohort BActive comparatorParticipants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 450μg.
Receives: Drug: IMM01-STEM
Cohort CActive comparatorParticipants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 900μg.
Receives: Drug: IMM01-STEM
Cohort DActive comparatorParticipants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 2000μg.
Receives: Drug: IMM01-STEM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0 to Day 28

Secondary outcomes (2)

  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).

    Measured: 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

    Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2022
  2. Study start13 Sep 2022
  3. Primary completion27 Jul 2026
  4. Study completion27 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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 2000μg.
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05211986
Sponsor's protocol ID
STEM-MYO
Acronym
STEM-MYO
Status last verified
Sep 2026
First submitted
29 Nov 2021
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMM01-STEM in people with Muscle Atrophy, run by Immunis, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of IMMUNA(IMM01-STEM) treatment in study participants with muscle atrophy related to KOA (time frame: Day 0 to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05211986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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