Could stem cell secretome beat standard care for knee arthritis?
NCT ID NCT07337863
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a substance made from stem cells (called secretome) can reduce pain and improve knee function in people with moderate knee osteoarthritis. Fifty adults aged 40-70 will receive either the secretome or a standard treatment (sodium hyaluronate) via injection into the knee. The goal is to see if the secretome works better for easing symptoms.
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-derived mesenchymal stem cell secretome
- What this could lead to
- If it works, this could offer a new way to ease knee pain and improve function in people with moderate knee osteoarthritis.
- What could go wrong
- This is an early-to-mid-stage trial with only 50 participants, so results may not apply to everyone. The secretome is experimental and its long-term safety and effectiveness are not yet known.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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. Diagnosed with primary OA in one or both knees based on American College of Rheumatology (Clinical and Rheumatology criteria). If both knees have OA, the knee with the OA grade that falls within the inclusion criteria (grade 2-3) will be selected. If both knees meet the inclusion criteria, the knee with the highest grade and the one that is most uncomfortable will be chosen. 2. Males or females in the age range 40-70 years 3. Symptomatic knee OA (defined by pain at the affected joint for at least 3 months before inclusion and visual analog scale 40 - 70 mm on a 100 mm Visual Analog Scale (VAS). 4. Radiographic evidence of grade 2 to 3 osteoarthritis (OA) based on Kellgren and Lawrence radiographic criteria. 5. Body mass index between 18 - 30 kg/m2 6. Female participants of childbearing age who agreed to use accepted methods of contraception during the course of the study. 7. Ability to provide written informed consent and willing to participate the study Exclusion Criteria: 1. Participants who, based on physical examination and clinical history (anamnesis), are in the active or acute phase of cardiac, pulmonary, hematological, hepatic, renal, systemic autoimmune, immunodeficiency, or coagulation disorders that may interfere with the administration of the study drug (Secretome or Sodium Hyaluronate) will be excluded, 2. Diagnosed with a meniscal rupture based on clinical history (anamnesis) and physical examination. If the anamnesis and physical examination show symptoms and signs of a meniscal rupture, further evaluation will be performed using ultrasound (USG), 3. Participants with significant axial deviation, defined by valgus or varus deformity observed during physical examination, will be excluded, 4. Participants with other pathological lesions on knee X-rays from the screening examination will also be excluded, 5. History of any form of secondary arthritis in the knee due to trauma, 6. History of surgery or major trauma to the knee joint 7. Has knee effusion, 8. Has any other inflammatory disorder of the knee joint 9. Diagnosed with active malignancy. 10. History of stem cell or secretome therapy. 11. Intra-articular injection of corticosteroid and/or prior treatment with Sodium Hyaluronate and/or platelet rich plasma (PRP) in past 3 months. 12. Use of NSAIDs and/or chondroprotective supplements, such as glucosamine and chondroitin sulfate, within 7 days before the trial, whether used orally, topically, or via injection, 13. Undergoing immunosuppressive therapy, or anticoagulant therapy, or corticosteroid therapy. 14. For women of child-bearing potential: positive pregnancy test or lactating (females who were planning pregnancy within the next year were excluded). 15. Enrolled in any other clinical trials within the past four weeks. 16. The principal investigator considers that the participant is ineligible for the clinical trial due to any reasons other than those listed above
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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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RSUP Dr. Mohammad Hoesin Palembang
Palembang, South Sumatera, Indonesia
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Other studies related to the condition(s) this trial covers.
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