Can stem cell molecules rebuild wasted muscles? new trial aims to find out

NCT ID NCT05211986

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This early-phase trial tests a new drug called IMM01-STEM, made from stem cell secretions, in 28 people with muscle wasting due to knee osteoarthritis. The main goal is to check safety and find the right dose. Participants receive injections and are monitored for side effects over several weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMM01-STEM (a mixture of regenerative molecules from stem cells)
What this could lead to
If it works, this could point toward a new way to rebuild muscle in people with knee osteoarthritis, potentially improving strength and mobility.
What could go wrong
This is an early, small study (28 people) focused on safety, not effectiveness. The treatment may cause side effects or fail to show benefit. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

13 people

The number who actually took part.

Started

Sep 2022

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. Not a woman of childbearing potential (WOCBP). OR 2. 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. Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Orthopaedic Specialty Institute

    Irvine, California, 92618, United States

  • University of California, Irvine - Alpha Stem Cell Clinic

    Orange, California, 92868, United States

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