Could amniotic fluid injections ease knee arthritis pain?
NCT ID NCT06704893
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether injections of amniotic suspension allograft (ASA) can reduce pain and improve function in people with knee osteoarthritis. 160 participants will receive either ASA, hyaluronic acid, or a saline placebo. Researchers will track pain, knee function, and quality of life for one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amniotic suspension allograft (ASA) injection
- What this could lead to
- If it works, this could offer a new non-surgical option to reduce knee pain and improve function in people with osteoarthritis.
- What could go wrong
- This is an early Phase 3 trial with only 160 participants. The treatment may not prove better than existing options like hyaluronic acid, and long-term safety is 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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- 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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18 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: 1. Age between 18 and 80 years. 2. Body mass index (BMI) less than 40 kg/m². 3. Symptomatic knee osteoarthritis with X-ray evidence graded 2 or 3 on the Kellgren-Lawrence (KL) grading scale. 4. Numerical Rating Scale (NRS) score (scale 1 to 10) for pain greater than 4 over the past 7 days. 5. Able to walk independently or with the aid of a cane. Exclusion Criteria: 1. Pregnant women or women planning pregnancy. 2. Regular use of anticoagulants. 3. Use of pain medications (except acetaminophen) within 15 days prior to injection. 4. History of substance abuse. 5. Patients who take additional knee symptom-relief medications during the study must report it to the research team; failure to comply will result in exclusion. 6. Corticosteroid or visco-supplementation injection into the affected knee within 3 months prior to enrollment. 7. Knee surgery on the affected side within 12 months before enrollment, or surgery on the contralateral knee within 6 months before enrollment. 9\. History of organ or hematopoietic stem cell transplant. 11. Current use of immunosuppressive agents. 12. Diagnosis of cancer within the past 5 years (except for treated basal cell carcinoma).
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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
2 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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Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital
RECRUITINGKaohsiung City, 833, Taiwan
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Kaohsiung Chang Gung Memorial Hospital
RECRUITINGKaohsiung, Taiwan, 833, Taiwan
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