Can Cord-Tissue stem cells rebuild aging muscles?
NCT ID NCT07808905
First seen Sep 09, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
Researchers are testing a stem cell therapy called EN001 in adults aged 60 and older who have sarcopenia, the age-related loss of muscle mass and strength. EN001 uses mesenchymal stem cells taken from Wharton's jelly, a tissue in the umbilical cord. Participants receive three intravenous infusions four weeks apart at one of several doses, or a placebo. The trial measures safety and whether the treatment improves physical performance and handgrip strength over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allogeneic early-passage Wharton's jelly-derived mesenchymal stem cells
- What this could lead to
- If it works, this could point toward a stem cell treatment that helps older adults rebuild muscle strength and move more easily.
- What could go wrong
- This is an early-stage trial with 132 participants, so researchers do not yet know if the cells help or if benefits last. Stem cell infusions can cause immune reactions or other side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
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 years and older
- 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: * 1\) Male or Female aged 60 years or older at the time of providing written consent. : Female subjects must meet one of the following criteria for postmenopausal women\* : * Postmenopausal women: * Natural amenorrhea for 12 months * At least 6 weeks after surgical menopause (bilateral oophorectomy) * 2\) Individuals diagnosed with sarcopenia at the time of screening, based on the diagnostic criteria in Section 15.1 of the Asian Working Group for Sarcopenia(AWGS) 2019 guidlines, meeting (1) or (2) together with (3): * (1) Handgrip Strength: \< 28kg(men), \<18kg(women) * (2) 6-Metre Walk test\<1.0m/s, or 5-Times Chair Stand Test ≥12seconds, or Short Physical Performance Battery(SPPB)≤9points * (3) Appendicular Skeletal Muscle Mass(ASM) by dual-energy X-ray absorptiometry(DXA):7.0kg/m\^2(men), \<5.4kg/m\^2(women) * 3\) Individuals with a nutritional status score of ≥8points on the Screening component of the Long Mini Nutritional Assessment (Long MNA) at the time of screening * 4\) Individuals with a body weight of ≥35 kg and a Body Mass Index (BMI) of ≥15 kg/m² and \<30 kg/m² at the time of screening * 5\) Individuals who have stably adhered to the diet and exercise regimen provided as part of this clinical trial during a run-in period of at least 4 weeks, and who are willing to comply with the regimen throughout the trial period * 6\) Individuals meeting the following laboratory test criteria at the time of screening and baseline: * Hemoglobin ≥10 g/dL, * White Blood Cell ≥2,500/μL, * Platelet ≥100,000/μL, * AST or ALT ≤3 × ULN, * International Normalized Ratio (INR) ≤1.3 * 7\) Men who have agreed to use the appropriate contraceptive method(s), as specified in the protocol, from the date of signing the informed consent form through the end-of-study visit * Appropriate contraception is defined as follows and is achieved by applying one or more methods of contraception : * Partner's use of hormonal contraceptives * Partner's placement of an intrauterine device(IUD) or intrauterine system(IUS) * Sterilization procedure or surgery in the participant or partner * Double contraceptive method: use of a male condom in combination with other contraceptive methods \[hormonal contraceptives, IUD/IUS placement, or sterilization procedure/surgery) * Abstinence: Absolute abstinence. If, in the examiner's judgment, the subject's age, occupation, lifestyle, or sexual orientation warrants contraception, strict abstinence from sexual intercourse is also acceptable. However, periodic abstinence (e.g. Karenda method, ovulation method, symptomatic temperature method), abstinence, and external vaginal ejaculation are not recognized as appropriate contraceptive methods. 8\) Individuals who(or whose legally authorized representative) have voluntarily agreed to participate in this clinical trial. Exclusion Criteria: * 1)Those with the following comorbidities confirmed at the time of screening and baseline * Patients with chronic kidney disease(CKD-EPI;Estimated Glomerular Filtration Rate(eGFR) \<30 mL/min) * Individuals with uncontrolled thyroid disease(hyperthyroidism or hypothyroidism) * Patients with uncontrolled diabetes(HbA1c \>8.5%) * Individuals with a neuromuscular or neurological disease (e.g., Parkinson's disease, amyotrophic lateral sclerosis \[ALS\], stroke affecting lower extremity function, muscular dystrophy, epilepsy, multiple sclerosis, etc.) * Individuals with severe cardiac disease classified as New York Heart Association (NYHA) Functional Classification III or IV (cardiomyopathy, unstable angina, myocardial infarction, valvular heart disease, arrhythmia, aortic disease, etc.) * Patients with uncontrolled hypertension((Systolic Blood Pressure (SBP) \>180 mmHg or Diastolic Blood Pressure (DBP) \>110 mmHg) * Any one of the serum virus tests (HBsAg, anti-HBc, anti-HCV, HIV Ag/Ab) is positive * (If anti-HBc positive) However, registration is possible if the HBV DNA test result is negative. * (If anti-HCV positive) However, registration is possible if the HCV RNA test result is negative. * Any malignancy within 5 years before screening (excluding basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or carcinoma in situ of the cervix may be enrolled even if the 5-year period has not elapsed, provided the investigator determines that the condition has been successfully treated and is in complete remission) * Any medical condition or history of surgery within 24 weeks prior to screening that may affect physical activity or function, including walking or exercise (e.g., fracture, severe knee or hip osteoarthritis, peripheral vascular disease) * 2\) Subjects with a confirmed history of the following treatments: * Systemic corticosteroids equivalent to prednisone \>10 mg/day at screening * Any of the following medications that may affect muscle at screening: * Growth hormones (e.g., insulin-like growth factor-1 \[IGF-1\] analogues, somatropin) * Sex hormones (e.g., testosterone, estrogen, dehydroepiandrosterone \[DHEA\]) * Ghrelin or megestrol acetate * Myostatin or myostatin inhibitors (e.g., stamulumab, domagrozumab, landogrozumab) * Bimagrumab * β-receptor blockers, ACE inhibitors, TNF-α antagonists, or GLP-1 agonists (Subjects receiving any of these medications at a stable dose for ≥12 weeks prior to screening and who plan to continue the treatment throughout the study may be enrolled.) * Troponin Activator * Prior treatment with any cell therapy or gene therapy at any time in their lifetime * Those who have received other investigational medicinal products or medical devices within 4 weeks prior to screening * 3\) Subjects with a Korean version of Montreal Cognitive Assessment (MoCA-K) score of less than 23 at screening * 4\) Persons with hypersensitivity to the components of clinical investigational products * 5\) Those who are unable to read or write * 6\) Those who are deemed inappropriate to participate in clinical trials according to the judgment of the investigator\* * Examples of inappropriate reasons include, but are not limited to, the following: * History of drug or alcohol dependence or abuse * Medical history (e.g., autoimmune diseases such as myositis, dystonia, etc.) or surgical history that may affect efficacy evaluations, other than those specified in the inclusion/exclusion criteria * Subjects who are currently participating in, or plan to participate in, high-intensity bodybuilding, muscle-building, or muscle-strengthening programs (However, routine physical activity is not restricted.)
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Samsung Medical Center
Seoul, South Korea
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