Stem cell shot could fix Worn-Out knees
NCT ID NCT07547735
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests whether a single injection of stem cells from umbilical cords can help people with knee osteoarthritis. 100 adults aged 40-70 will receive either a low or high dose of stem cells or a placebo. The study measures changes in pain, stiffness, and function over time, aiming to find a treatment that goes beyond just symptom relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord mesenchymal stem cells (UC-MSCs)
- What this could lead to
- If it works, this could point toward a new treatment that repairs cartilage and reduces pain in knee osteoarthritis, potentially delaying or avoiding joint replacement.
- What could go wrong
- This is an early Phase 2 trial with only 100 people, so results may not apply to everyone. The treatment is a single injection, and its long-term safety and effectiveness are still unknown.
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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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40 to 70 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: 1. Prior to conducting any assessment, written informed consent must be obtained; 2. Able to communicate well with researchers during screening, understand and comply with experimental requirements; 3. Age range from 40 to 70 years old (including threshold), regardless of gender; 4. Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) within the range of 18-28 kg/m2 (including critical values); 5. According to the diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)", subjects diagnosed with knee osteoarthritis (see Annex 1 for details); The course of knee osteoarthritis is more than 4 weeks; Other: 15\) There are contraindications to MRI examination or unwillingness to undergo MRI examination; 16) Hepatitis B, hepatitis C, AIDS, syphilis serological test positive pathogens; 17) Pregnant or lactating women, or male or female patients who tested positive for blood pregnancy during screening or have planned childbirth within 3 months after medication; 18) Patients who have received live vaccines or attenuated live vaccines within one month before administration; 19) Patients who have participated in clinical trials of other drugs or devices within 3 months prior to administration; 20) Patients with poor compliance, poor communication skills, inability to adhere to follow-up, and inability to complete the entire trial; 21) The researchers believe that it is not suitable for participants to enter this experiment. 6\) The target knee joint X-ray Kellgren Lawrence radiological grading (K-L IV grade) is II-III grade. Patients diagnosed with knee osteoarthritis on both sides should have non target knee joint symptoms, signs, and grading that do not exceed the target knee joint; 7) MRI examination shows partial or full layer damage to the cartilage of the knee joint; 8) A VAS score of ≥ 4 and ≤ 7 for knee joint pain at least 48 hours after discontinuing the use of all painkillers during screening; 9) Patients who use analgesic therapy (taking paracetamol/acetaminophen) to control local pain in the target knee joint agree to discontinue the use of similar analgesics 2 weeks prior to administration, and only allow NSAID as a rescue drug; Patients who use glucosamine, chondroitin, opioid drugs, or diacetate, glucosamine, etc. must agree to discontinue such drugs from 2 weeks prior to administration. \- Exclusion Criteria: * History of local/systemic treatment: 1. Individuals with a history of knee joint infection, surgery, and radiation therapy within 6 months prior to administration; 2. Combined instability of the knee joint (anterior and posterior cruciate ligaments, medial and lateral collateral ligaments), rupture, relaxation, or external deformity of the knee joint; 3. According to researchers, diseases that may interfere with knee joint function assessment, such as symptomatic lower back pain, lumbar disc herniation, and hip joint pain in the target knee joint; 4. According to the judgment of researchers, local diseases that may confuse knee joint function assessment include but are not limited to septic arthritis, reactive arthritis, clinically recurrent pseudogout, chondrocalcinosis, or joint fractures; 5. Within 3 months prior to administration, any medication injection treatment (including intra-articular injection of growth factors, hormones, or sodium hyaluronate) or lavage surgery has been received in the knee joint (target side) cavity; 6. Merge intra-articular or periarticular tumors (such as knee synovial chondroma, pigmented nodular synovitis, etc.); Systemic diseases and treatment history: 7. Various serious systemic diseases such as neurological disorders, respiratory disorders, heart diseases (NYHA grade III and above), and liver dysfunction (ALT\>3)×ULN or AST\>3×ULN, renal dysfunction Cr\>2×ULN or BUN\>2×ULN, coagulation dysfunction (INR\>1.5), or severe hematological disorders (such as grade 3 or above anemia, hemoglobin (Hb)\<8 g/dL, grade 2 or above thrombocytopenia, PLT\<75×10 \^ 9/L); 8. Diagnosed as systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus, or other systemic diseases that may confuse KOA assessment (such as fibromyalgia); 9. Subjects who receive long-term (\>14 days) oral corticosteroids\>5 mg/day within 3 months prior to administration, or who require long-term glucocorticoid treatment during the trial period; 10. Previously received stem cell therapy; 11. Uncontrolled hypertension is defined as systolic blood pressure (SBP)\>160 mmHg or diastolic blood pressure (DBP)\>100 mmHg during screening; 12. Having a history of tumors, mental illness, severe autoimmune diseases, hematological diseases, and long-term use of immunosuppressants; 13. Have a history of alcohol and prohibited drug abuse; 14. Has a history of hypersensitivity to protein drugs;
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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
3 sites. 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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Guangzhou First People's Hospital
RECRUITINGWuhan, China
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Wuhan Fourth Hospital
RECRUITINGWuhan, China
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Wuhan Third Hospital
RECRUITINGWuhan, China
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