A Phase 1 interventional study of Autologous Mesenchymal Stem Cells in Musculoskeletal Pain, Knee Osteoarthritis and Cartilage Injury, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University Hospitals Cleveland Medical Center · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 155 studies in Musculoskeletal Pain with a site in United States — 29 open to participants now, 37 under way, 1 of them phase 3. Musculoskeletal Pain · United States.
Among the 155 studies in Musculoskeletal Pain with a site in United States, this one is the 121st largest by enrollment of the 136 interventional ones that give a count, is one of 12 that started in 2018, is one of 5 in phase 1, and was the 45th registered.
516 studies on the registry are indexed under Musculoskeletal Pain; 128 are open to participants now.
Browse Musculoskeletal Pain studies →29 of the 155 studies in Musculoskeletal Pain with a site in United States are open now. Recruiting first, the newest first:
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+
Margaret L Gourlay, MD, MPH · Sites in United States
Ages 50–64
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 14–26
University of Utah · Sites in United States
Ages 40–80
Butler Hospital · Sites in United States
Ages 55+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 66 Musculoskeletal Pain studies recruiting now, 29 (44%) set no upper age limit and 31 (47%) stop at 75 or younger; 8 take children under 18; 18 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
155 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 10 · Phase 3 3 · Phase 4 6
First in 2002; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 70 across 370 interventional studies indexed under Musculoskeletal Pain.
Median enrollment 60 across the 136 interventional studies, 195 across the 19 observational. Of the 108 that completed or were terminated, 41 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 155 have an industry lead sponsor. The 10 most frequent:
University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
University Hospitals Cleveland Medical Center has 1 study filed under Musculoskeletal Pain — fewer than ten, so there is no comparison to draw.
13 of the studies in Musculoskeletal Pain with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02979574Memorial Sloan Kettering Cancer CenterPEACE: Comparing Chronic Pain Treatment Options | 2026-11 |
| NCT06867757Stanford UniversityTargeted Realtime Assessment of Chronic Pain in Youth | 2026-11 |
| NCT07393503State University of New York at BuffaloMusculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries | 2027-01 |
| NCT06886906Indiana UniversityExploring the Acute and Dynamic Relationships Between Movement and Pain in Older Adults With Musculoskeletal Pain | 2027-01-01 |
| NCT06119698Massachusetts General HospitalImproving Health for Older Adults With Pain Through Engagement | 2027-04-01 |
Add all 13 to your calendar (.ics) → With an account.
Among the 155 studies in Musculoskeletal Pain with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative treatment modality. Additionally, this modality may have reparative or regenerative potential, which could lead to the first treatment for osteoarthritis that treats the underlying disease as opposed to symptomatic control.
Additionally, there are no acceptable non-surgical treatments for focal chondral defects of the knee. Surgical treatments that do exist have diminished outcomes if performed on patients older than age 30-40 years. If successful, intra-articular MSC injections into the knee would represent the first non-operative treatment for focal chondral defects and also represent a potential option for treatment in patients over the age of 30-40 years.
This trial will be a prospective, single-center phase I pilot study to evaluate the safety and tolerability of a single intra-articular injection of autologous bone marrow-derived MSCs in 16 subjects, 8 who have knee osteoarthritis and 8 who have a focal chondral defect in the knee. Patients will undergo a bone marrow harvest procedure at the Dahms Clinical Research Unit (DCRU) of University Hospitals Cleveland Medical Center. MSCs will be isolated and expanded. After approximately 2-3 weeks, patients will return for an intra-articular injection of 50x106 MSCs Subsequent study visits will occur on post-injection day 7 and months 2, 6, 12, and 24. Safety of intra-articular injection of MSCs will be evaluated at study visits by interval history, physical examination and assessment of any adverse events that are observed/reported. Additionally, efficacy will be evaluated by having patients complete functional outcome measures including: Visual Analog Score (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Form, and Lysholm Knee Scale. These will be completed at the pre-treatment visit and then repeated at the 2, 6, 12, and 24-month follow-up visits. Lastly, T1 rho and T2 mapping on magnetic resonance imaging (MRI) will be used to assess for improved cartilage quality after intra-articular injection of MSCs. An MRI will be obtained at the pre-treatment visit. At the 12 and 24 month follow up visit, additional MRIs will be obtained and analyzed to compare the pre-treatment MRI to post-treatment MRIs.
Inclusion Criteria:
Knee Osteoarthritis Subjects
Focal Chondral Defect Subjects
Inclusion Criteria:
Exclusion Criteria:
Concurrent participation in another trial involving systemic administration of agents (within the previous 30 days), or have received prior intra-articular injection of any form
to MRI:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The OA subgroup will be patients aged 18-60 years who have chronic knee pain due to early OA that have not responded to conservative, non-invasive measures such as physical therapy, medications, and activity modification.
Biological: Autologous Mesenchymal Stem Cells
The focal chondral defect subgroup will be patients aged 18-60 years who participate in recreational or professional sports and are symptomatic from a focal chondral defect shown on MRI.
Biological: Autologous Mesenchymal Stem Cells
Bone marrow will be harvested from each individual patient's iliac crest, followed by stem cell isolation, expansion and preparation. Stem cell will be injected approximately 3-4 weeks after bone marrow harvest, injecting 50x10\^6 MSCs in the knee via a medial parapatellar approach under sterile technique in 8 patients with generalized knee OA or focal chondral defects.
Also known as: Stem Cell Injection
Primary Endpoint: Incidence of treatment emergent major adverse events directly related to MSC injection
Establish the safety and tolerability of expended autologous intraarticular MSC injections into the knee by the incidence of no major adverse events (AE) determined to be directly related to MSC injection by the end of the 24 month follow up period. An AE is any untoward medical occurrence during the clinical investigation in a patient administered stem cells that does not have a causal relationship with the treatment that occurs from the time of consent through the last clinic visit at 24 months post-injection. An AE is therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the administration of the investigational product, whether or not related to that investigational product. AEs will be described by duration (start and stop dates and times), severity, outcome, treatment and relation to investigational product, or if unrelated, the cause.
Time frame: 24 months
Secondary Endpoint: Development of Pain following injection based on Visual Analog Scale scoring.
Pain will be analyzed based on visual analog pain scores (VAS) by clinically and statistically significant amounts by six-month follow up and maintain these improvements throughout the two-year study period. Data analysis will be performed separately on the knee osteoarthritis subgroup and on the focal chondral defect subgroup. This will consist of a comparison of mean values for VAS scoring scales pre-operatively and at follow-up visits at 2, 6, 12, and 24-months. Clinically significant outcomes will be determined based on the minimal clinically important difference (MCID) occurring for each respective scale, which is defined as the smallest change score needed for the effect to be considered clinically relevant; described below. Specifically, VAS represents a patient-reported measurement tool used to quantify perceived level of pain, graded on a scale from 0 to 10 with 0 representing no pain and 10 representing the worse pain possible.
Time frame: 2, 6, 12 and 24 months
Secondary Endpoint: Clinical Evaluation of Injection based on functional outcomes scoring using KOOS, IKDC and Lysholm scoring scales.
Functional outcomes will be evaluated clinically and statistically throughout the study period. Data analysis will be performed on the knee osteoarthritis and the focal chondral defect subgroups. Mean values for Knee Injury and Osteoathritis Outcome Score (KOOS), International Knee Documentation Committee Score (IKDC), and Lysholm scoring scales pre-operatively and at follow-up visits at 2, 6, 12, and 24-months will be compared. KOOS is a qualitative assessment of knee pain, stiffness, function, and quality of life within the last week. The IKDC is a quantitative assessment of knee symptoms with daily and sporting activities with a high score of 100 representing no limitations or pain, with lower scores signifying pain or limitations in knee function. The Lysholm score rates knee pain and symptoms with a high score of 100, with scores \> 90 representing excellent function and scores \<65 representing poor function.
Time frame: 2, 6, 12 and 24 months
Secondary Endpoint: Reparative potential of intra-articular MSCs based on improvement in cartilage quality using MRI.
T1 rho and T2 mapping observed from MRIs at 1-year and 2-year follow-up to determine the reparative potential of intra-articular MSCs. T1 rho values increase as degenerative changes worsen; therefore, as cartilage quality improves, it is expected that T1 rho values would increase. T2 mapping values primarily reflect changes in water content and collagen anisotropy. Focal areas of increased T2 mapping values correlate with focal areas of cartilage damage; therefore, as cartilage quality improves, T2 mapping values would decrease. Clinically significant changes will be observed by comparing T1 rho and T2 values in areas of relatively preserved hyaline cartilage within our patients with the areas of degenerative change to utilize an internal control. Data analysis will consist of a comparison of mean values for quantitative T1 rho and T2 mapping data pre-operatively and at follow-up visits at 12 and 24-months.
Time frame: 12 and 24 months
Plan to share: No — No patient protected health information will be shared outside the primary research team. All patient data will be de-identified.
Ran from Oct 2018 to primary completion in Jul 2026, 93 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Stem Cell
University Hospitals Cleveland Medical Center →