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Could a single stem cell shot fix your knee pain?

NCT ID NCT03477942

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests whether injecting a patient's own stem cells into the knee can safely treat osteoarthritis and cartilage defects. Sixteen adults with knee pain will receive one injection of stem cells grown from their own bone marrow. Researchers will track side effects and measure pain, function, and cartilage quality over two years.

What this could mean

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

Active substance
autologous mesenchymal stem cells (patient's own bone marrow stem cells)
What this could lead to
If it works, this could point toward a non-surgical treatment that repairs knee cartilage and reduces pain, potentially delaying or avoiding knee replacement.
What could go wrong
This is a very early phase 1 trial with only 16 people, so it is primarily checking safety, not effectiveness. The stem cell approach may not work or could cause side effects like pain or infection.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Knee Osteoarthritis Subjects 1. Male or female 18-60 years of age 2. Confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings 3. Unilateral chronic knee pain \>4 months 4. Imaging findings consistent with mild-moderate generalized cartilage degeneration (MRI chondropathy or radiographic changes) 5. Failed non-invasive modalities of treatment 6. Subjects must have the ability to understand and the willingness to sign a written informed consent document 7. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \<1% per year during the treatment period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\<12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Period abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception Focal Chondral Defect Subjects Inclusion Criteria: 1. Male or female 18-60 year of age 2. Knee pain and/or effusion 3. Inability to continue or difficulty in participation in recreational or professional sport 4. MRI with Outerbridge Grade 4 focal chondral defect 5. Subjects must have the ability to understand and the willingness to sign a written informed consent document 6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \<1% per year during the treatment period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\<12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Period abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Exclusion Criteria: 1. Radiographic findings consistent with Kellgren-Lawrence Stage 4 disease 2. Focal chondral defect 3. Major axial deviation (\>5 degrees varus or valgus) 4. Concomitant ligamentous or meniscal injury 5. BMI \> 40 as defined by NIH Clinical Guidelines Body Mass Index 6. Women who are pregnant, breastfeeding or unwilling to practice birth control during participation in the study 7. Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days), or have received prior intra-articular injection of any form • Or plans to participate in any other allogeneic stem cell therapy trial during the 2-year follow-up period 8. Symptomatic active cardiac or respiratory disease that requires scheduled use of medication 9. Neurologic disorder including, but not limited to epilepsy, Parkinson's disease, dementia, cerebrovascular disease, tumor of the nervous system, and amyotrophic lateral sclerosis. 10. Psychiatric disorder including, but not limited to schizophrenia, bipolar disorder, personality disorder, depression, anxiety, or any other mental illness that would prevent the completion of the study 11. Current immunosuppression from medication or disease 12. History of systemic malignancy 13. History of infection with hepatitis B, C, or HIV 14. History of inflammatory arthropathy 15. History of prior local knee infection 16. Major surgeries, other than diagnostic surgery within 4 weeks 17. Contraindication to MRI: * Indwelling medical devices such as pacemakers, aneurysm clips, etc. * Indwelling metal from any other cause (trauma, etc.). To be excluded with history and/or radiographs, as necessary 18. Screening hematology with white blood cell count \< 4.5 x 109 cells/L, hematocrit \<30%, and platelets \<150 x 109 platelets/L 19. Have a known history of hypersensitivity or anaphylactic reaction to Dimethyl sulfoxide (DMSO) 20. Have been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an inpatient substance abuse program 21. Subject unlikely to complete the study as determined by the Investigator 22. Subjects must have normal marrow function, and be clinically stable with no significant changes in health status within 2 weeks prior to cell collection that the PI/Sub-Investigator deems relevant to exclude from participation. (See below for details of the cell collection procedure)

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Conditions

The condition(s) this trial relates to.

Musculoskeletal Pain osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

More trials for these conditions

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