Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can your own fat cells rebuild a damaged knee?

NCT ID NCT04368806

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This trial is testing whether a single injection of stem cells taken from a patient's own belly fat can ease the pain and improve the function of knees damaged by osteoarthritis. Half of the participants will receive the stem cell treatment, while the other half will get a placebo (salt water with a bit of their own blood). The study will follow participants for 48 weeks to see if the stem cells help more than the placebo in reducing pain and improving daily activities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JointStem, a stem cell therapy made from a patient's own fat tissue
What this could lead to
If successful, this could offer a new way to reduce knee pain and improve mobility in people with osteoarthritis, potentially delaying or avoiding joint replacement surgery.
What could go wrong
This is an early-stage trial, so the treatment may not work better than a placebo. There are also risks of side effects from the procedure to harvest and inject the cells.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

173 people

The number who actually took part.

Started

May 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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 of any race, adult aged 18 years or older 2. Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria) 3. Subject who has ≥ 45 on WOMAC function score at Screening and Baseline 4. Subject who has knee pain ≥ 70 mm for the study knee out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline 5. Subject who has radiographic evidence of grade 3 osteoarthritis in the study knee based on the Kellgren and Lawrence radiographic criteria 6. Subject who has a varus angle of 5 degrees or less confirmed through radiography 7. Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to Screening and does not improve symptoms with non-operative treatment options 8. Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (acetaminophen \< 3.25 g per day) at least 72 hours prior to Screening and throughout the duration of study 9. Subject who is willing and able to give written informed consent for participation in the study \<Exclusion Criteria\> 1. Subject who has Body Mass Index (BMI) \> 35 kg/m2 2. Subject judged by the investigator to have a history of clinically significant disease(s) (i.e., uncontrolled comorbid disease, kidney diseases, liver diseases, endocrine diseases, etc., but not limited to these diseases) that may affect the patient's participation in the study. 3. Subject who has any of following clinically significant diseases: * Autoimmune diseases * Paget's disease, ochronosis, acromegaly, hemochromatosis, or Wilson's disease * Genetic diseases (hyperkinesia, collagen gene abnormality, etc.) * Inflammatory joint disorders (e.g., rheumatoid inflammation) * Infectious joint disorders (e.g., septic arthritis) * Other joint disorders (e.g., gout, recurrent pseudogout, articular fracture, primary osteochondrosis, villonodular synovitis) 4. Subject who has any history of cancer and/or currently receiving treatment for a current cancer diagnosis. 5. Subject who is positive in pathogenic test (HIV, viral hepatitis, or syphilis) 6. Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening 7. Subject who has received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening 8. Subject who has history of prolotherapy, or platelet rich plasma injection within 6 months prior to Screening 9. Subject who has received long-acting hyaluronic acid injection (e.g., Synvisc-One®, etc.) within 6 months prior to Screening 10. Subject who has history of stem cell therapy 11. Subject who has significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment): * Serum ALT and AST \> 2 x upper limit of normal * Serum creatinine out of normal range * PT/INR out of normal range * Hemoglobin \< 10 g/dL for female subject and hemoglobin \< 11 g/dL for male subject * Platelets out of normal range 12. Subject for whom the investigator judges the lipoaspiration can cause any problem 13. Subject who has history of local anesthetic allergy 14. Subject who has taken anti-inflammatory drugs (prescription and non-prescription NSAIDs), symptomatic slow acting drugs (glucosamine, chondroitin sulfate, diacerhein etc.), or oral steroids (prednisone etc.) within 14 days prior to Screening (however, those who undergo a 14-day wash-out period can participate.) 15. Subject who is an active drug/alcohol abuser 16. Pregnant or breast-feeding women, or women or men who are not using appropriate method of contraception (appropriate method includes hormones, bilateral tubal ligation, and barrier method with spermicide, and intra-uterine device for women and vasectomy and barrier method with spermicide for men; subjects should agree to use appropriate method) 17. Subject who is enrolled in any other clinical trials within 3 months from screening 18. Subject who received the COVID-19 vaccines within 1 week from Visit 2 (Lipoaspiration, baseline) 19. Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Osteoarthritis, knee are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Contacts and locations

Locations

  • BioSolutions Clinical Research Center

    La Mesa, California, 91942, United States

  • Keimyung University Dongsan Hospital

    Daegu, Korea, Republic of, 42601, South Korea

  • Kyung Hee University Hospital At Gangdong

    Seoul, Korea, Republic of, 05278, South Korea

  • Kyung Hee University Medical Center

    Seoul, Korea, Republic of, 02447, South Korea

  • Neurovations Research

    Napa, California, 94558, United States

  • Newport Therapeutics

    Newport Beach, California, 92660, United States

  • Smg-Snu Boramae Medical Center

    Seoul, Korea, Republic of, 07061, South Korea

  • Source Healthcare

    Santa Monica, California, 90403, United States

  • TriWest Research Associates

    El Cajon, California, 92020, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.