IMM01-STEM for Muscle Wasting in Knee Osteoarthritis

(STEM-MYO Trial)

Recruiting at 2 trial locations

Overseen By Erin Curry, PA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Immunis, Inc.

Must not be taking: Narcotics, Anti-inflammatories, Investigational drugs

Disqualifiers: Severe KOA, Malignancy, Diabetes, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IMM01-STEM for muscle wasting in individuals with knee osteoarthritis. The goal is to determine if different doses of this treatment are safe and tolerable. Participants will receive various doses of IMM01-STEM through muscle injections twice a week for four weeks. Individuals with moderate knee osteoarthritis, noticeable quadriceps weakness, and the ability to walk over 50 feet without assistance may be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications to join the trial?

The trial requires that you stop using systemic oral or intravenous steroids for at least 6 months before joining. Additionally, you cannot take narcotic pain medication, local anti-inflammatory drugs, or other investigational drugs. If you've changed medications for conditions like diabetes or hypertension within a month before screening, you may not be eligible.

Is there any evidence suggesting that IMM01-STEM is likely to be safe for humans?

Research has shown that IMM01-STEM, a treatment for muscle wasting in knee osteoarthritis, has undergone safety testing in earlier studies. Initial results suggest that people generally tolerate the treatment well. In these studies, participants received varying doses of IMM01-STEM to assess their responses. Most participants did not experience serious side effects, indicating the treatment was generally safe for them.

However, as IMM01-STEM remains in the early testing stages, ongoing research is necessary to confirm its safety. This research is crucial for understanding and managing any potential side effects. Overall, early studies provide a positive view of the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for muscle wasting?

Most treatments for muscle wasting in knee osteoarthritis focus on pain relief and inflammation control, often using medications like NSAIDs or corticosteroids. Unlike these traditional methods, IMM01-STEM is unique because it directly targets muscle regeneration through intramuscular stem cell therapy. Researchers are excited about IMM01-STEM's potential to not just manage symptoms but to promote actual muscle repair and strengthening. This could lead to improved mobility and quality of life for patients, offering a fundamentally different approach compared to current treatments.

What evidence suggests that IMM01-STEM might be an effective treatment for muscle wasting in knee osteoarthritis?

Research has shown that IMM01-STEM may help with muscle loss in people with knee osteoarthritis. Early results from past studies suggest this treatment can reverse muscle loss, a common issue in this condition. Participants in those studies experienced improvements in muscle strength and function with IMM01-STEM. Importantly, no serious safety issues have been reported so far. These findings suggest that IMM01-STEM could effectively treat muscle wasting linked to knee osteoarthritis. ^{3 4 6 7 8}

Who Is on the Research Team?

Tom Lane, PhD

Principal Investigator

Chief Science Officer at Immunis, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with moderate knee osteoarthritis and muscle weakness who can walk unassisted, have a BMI under 40, are not pregnant or breastfeeding, agree to use contraception, and do not have certain health conditions like severe liver disease or recent drug abuse. Participants must also be non-smokers for at least 10 years.

Inclusion Criteria

My thigh muscles are weak.

I am not pregnant or breastfeeding and either cannot become pregnant or will follow the study's birth control advice.

Your vital signs, like your temperature, blood pressure, and heart rate, are within certain normal ranges before starting the study.

Exclusion Criteria

You have tested positive for hepatitis B or hepatitis C within the last 3 months.

You have had a problem with drinking alcohol or using drugs regularly in the past 3 months.

I changed my medication for another health condition within the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive twice weekly intramuscular administration of IMM01-STEM for 4 weeks

4 weeks

8 visits (in-person)

Safety Follow-up

Participants are monitored for safety with clinic visits 3 days after the last injection and then monthly for 3 months

3 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• IMM01-STEM

Trial Overview The study tests the safety of IMM01-STEM in patients with muscle wasting due to knee osteoarthritis. It's an open-label trial where everyone gets the treatment; doses increase over time to find out what's safe.

How Is the Trial Designed?

Group I: Cohort D Active Control 1 Intervention

Participants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 2000μg.

Group II: Cohort B Active Control 1 Intervention

Participants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 450μg.

Group III: Cohort A Active Control 1 Intervention

Participants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 225μg.

Group IV: Cohort C Active Control 1 Intervention

Participants will receive twice weekly intramuscular (im) administration of IMM01-STEM for 4 weeks with a dose of 900μg.

Who Is Running the Clinical Trial?

Immunis, Inc.

Lead Sponsor

Trials

3

Recruited

70+

Citations

1. immunisbiomedical.com immunisbiomedical.com/metabolism/

STEM-META: Targeting Muscle Performance Immunis is planning a Phase 2 placebo-controlled clinical trial to continue safety and efficacy assessments of IMM01-STEM on addressing muscle performance in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06600581

NCT06600581 | Safety and Efficacy of IMM01-STEM ... Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness. ClinicalTrials.gov ID NCT06600581.

3. ucihealth.org ucihealth.org/about-us/news/2022/11/uci-opens-first-stem-cell-clinical-trial-to-treat-knee-arthritis

UCI tests first stem cell therapy to treat knee arthritis UCI Health and UCI Alpha Clinic have launched the first US clinical trial to test the safety and tolerability of IMM01-STEM in patients with knee ...

4. immunisbiomedical.com immunisbiomedical.com/news-media/press-releases/immunis-successfully-completes-its-phase-1-2a-clinical-trial-targeting-muscle-atrophy/

Immunis Successfully Completes its Phase 1/2a Clinical ... This parallel STEM-META program will focus on the efficacy of IMM01-STEM against a placebo on muscle and overall physical function in seniors ...

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/immunis-achieves-breakthrough-in-muscle-atrophy-trial/

Immunis Achieves Breakthrough in Muscle Atrophy Trial ... IMM01-STEM in reversing muscle atrophy in older adults with knee osteoarthritis. Initial data suggest positive outcomes with no reported ...

6. hpscreg.eu hpscreg.eu/browse/trial/184

Safety and Tolerability of IMMUNA(IMM01-STEM) in ... This will be an open-label, dose escalation study to assess the safety and tolerability of IMMUNA(IMM01-STEM), a secretome product derived from partially ...

7. ctv.veeva.com ctv.veeva.com/study/safety-and-tolerability-of-immuna-imm01-stem-in-patients-with-muscle-atrophy-related-to-knee-osteoa

Safety and Tolerability of IMM01-STEM in Patients With ... An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee ...

8. c2c.uci.edu c2c.uci.edu/vi/uci-opens-clinical-trial-of-stem-cell-derived-therapy-for-muscle-atrophy/

UCI opens clinical trial of stem cell-derived therapy for muscle ... ... safety and tolerability of IMM01-STEM in patients with muscle atrophy related to knee osteoarthritis. Up to 18 patients ranging in age from 50 to 75 will be ...