Could stem cell secretions help seniors regain muscle strength?
NCT ID NCT06600581
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether a substance called IMM01-STEM, made from secretions of stem cells, can safely improve muscle performance in seniors aged 60-80 who have both obesity and muscle weakness (sarcopenic obesity). Participants receive injections twice a week for a period, and researchers monitor side effects and changes in walking speed and grip strength. The study involves 55 people and compares the treatment to a placebo.
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 molecules secreted by stem cells)
- What this could lead to
- If it works, this could lead to a new treatment that helps older adults with obesity and muscle weakness regain strength and mobility.
- What could go wrong
- This is a small, early-phase trial with only 55 participants. The treatment may not work better than placebo, and side effects are still being studied.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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60 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Sex: male or female * Age 60 to 80 years of age at the time of signing the informed consent. * Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria * Disease characteristics: To be eligible, the participant must meet at least one criterion for obesity and at least one criterion for sarcopenia, as defined below: Obesity: Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association) Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for women (World Health Organization) Sarcopenia: Grip strength women: \< 16 kg, men: \< 27 kg in the dominant hand Gait speed \< 0.8 m/s (men and women) Acceptable stages: STAGE I: No complications attributable to altered body composition and skeletal muscle functional parameters STAGE II: Presence of up to two complications attributable to altered body composition and skeletal muscle functional parameters (e.g. metabolic syndrome components, disabilities resulting from high fat mass and/or low muscle mass, cardiovascular and respiratory disease). Limitations apply (see exclusion criteria). * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the STEM-META clinical protocol * In order to understand the nature of this study it is expected that most participants will be able to speak, read, and understand English, or Spanish however, additional translations of the informed consent may be made available after study initiation to include additional languages for participants * Study participant is willing and able to comply with all study requirements, according to the judgment of the Investigator. * To be eligible for enrollment and for each treatment administration, the vital signs pre-dose, should be in the following ranges. If the vitals are outside of the range, will be reassessed 3 times at 10 minutes resting intervals. Heart rate \>50 and \<100 bpm Systolic pressure \>100 and \<170 mmHg Diastolic pressure \>50 and \<100 mmHg Blood oxygenation (by pulse-oximetry) \>95% Exclusion Criteria: * Unmanaged/uncontrolled comorbidities (examples include high blood pressure, hyperglycemia, unstable angina, deep vein thrombosis, hepatic cirrhosis, peptic ulcers, complicated GERD, COPD, asthma etc.) as judged by the investigator. * Type 1 Diabetes Mellitus, insulin-dependent Type 2 Diabetes mellitus, or hemoglobin A1C level \>7.0% * Severe obesity, or class III obesity (CDC criteria, BMI \>40) * Current diagnosis of major psychiatric disorders that may impact participation, as judged by the investigator. * Conditions that interfere with gait balance or mobility, such as severe arthritis of lumbo-sacral area, hip or lower extremities if gait speed is used for inclusion criteria * Conditions that interfere with ability to measure grip strength including hand arthritis, carpal tunnel syndrome and elbow tendinitis if hand grip criteria is used for inclusion * Study participant has current or past history of invasive malignancy (5 years) excluding non-melanoma skin cancer. * Inflammatory conditions requiring regular use of oral or parenteral corticosteroids (Raynaud phenomenon, scleroderma, rheumatoid arthritis, LED etc.). * Cushing's syndrome, Graves disease (hyperthyroidism), or other condition of hormone imbalance caused by genetic or auto-immune disorder. Exceptions include controlled hypothyroidism and polycystic ovarian syndrome. * Severe cardiovascular disease (including New York Heart Association \[NYHA\] class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator) * Parkinson's disease, multiple sclerosis or other progressive neurological disorders * Renal disease requiring dialysis, or known renal insufficiency (moderate or severe reduction in GFR≤30 ml/min/1.73 m2) * Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline functional tests * Study participant is taking or has taken a prohibited medication as defined in Section 6.8.2 of the clinical protocol. * Participant has had a change in medication to manage comorbid condition(s) (including diabetes, hypertension, asthma, and cardiovascular disease) within 1 month of the Screening visit. * Weight loss (bariatric) surgery of any type including biliopancreatic diversion with duodenal switch, gastric bypass, sleeve gastrectomy, adjustable gastric banding, 1 year prior enrollment. * Study participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study. * Study participant has been exposed to an investigational drug or device within 1 year, prior to the first dose of IMP, or is currently participating or planning to participate in another study of an investigational drug. * Woman of Childbearing Potential (WOCBP) (defined as women with less than 12 months of amenorrhea). * Unable to understand and/or perform the functional tests, as judged by the Investigator. * Current physical/rehabilitation therapy (except for passive physical therapy) * Substance abuse (including but not limited to alcohol, cannabis, narcotics, pain medication) as judged by the investigator. * Smoking or vaping of products containing nicotine, tobacco or any other products, currently and in the past 1 year. * Study participant is known positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) or human immunodeficiency virus-1/2 antibody (human immunovirus 1/2Ab) * All participants will be encouraged to follow a healthy diet. Caloric restriction will not be pursued. * Smoking of tobacco, marijuana or any other inhaled products (vaping) are prohibited during treatment and during the follow-up period * There is no restriction on caffeine consumption * Occasional alcohol consumption is acceptable, however the participants will be prohibited to consume alcohol 72 hours (3 days) prior medical and laboratory visits * All participants in the trial (including placebo group) will be encouraged to increase daily physical activities. The participants can follow any preferred physical activity (walking, running, swimming, bicycle, treadmill, etc.), it can be evaluated by summed duration of a variety of activities, such as household work. The activity is measured by the sensors of the wearable activity tracker; thus, the nature of the activity is not critical. * Activities that are conductive to falls and accidents are discouraged. Examples include horse riding, skiing, skydiving, scuba diving, mountain biking, bungee jumping, etc. * Participant must be able to wear an activity tracker device daily, optional during sleep, and must be aware of the requirements to charge the tracker or transfer the data.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johnson Country Clinical Trials (JCCT)
Lenexa, Kansas, 66219, United States
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National Institute of Clinical Research (NICR)
Garden Grove, California, 92844, United States
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National Institute of Clinical Research (NICR)
Pomona, California, 91768, United States
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Tekton Research
Wichita, Kansas, 67218, United States
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