Osteoarthritis, HipPhase 1NCT03608579
Autologous Culture Expanded Adipose Derived MSCs for Treatment of Painful Hip OA
A Phase 1 study testing Autologous Adipose Derived Mesenchymal Stromal Cells in people with Osteoarthritis, Hip, run by Mayo Clinic at 1 site in United States.
Trial summary
Will injection(s) of autologous culture-expanded AMSCs be safe and efficacious for treatment of painful Hip OA, and if so, which dosing regimen is most effective? Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Autologous Adipose Derived Mesenchymal Stromal Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
- Male or female ages 18-65 years
- Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit
- Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- Chronic (> 3 months), unilaterally symptomatic, primary hip OA. Patients with episodes of contralateral hip pain that is asymptomatic at the time of enrollment will be eligible for inclusion. However, as outlined in the primary study endpoints, patients with previous episodes of contralateral hip pain who experience a repeat episode of contralateral pain similar to their established pattern of pain during the course of the trial will not be considered as having experienced an adverse event.
- Radiographic hip OA of Tönnis Grade 1 - 2, accompanied by at least mild sclerosis and joint space narrowing, as agreed upon by two study co-investigators without underlying structural hip abnormalities
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- Previous 6 week or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications or injection therapy (e.g. cortisone)
- Able to routinely walk without assistance (e.g. cane, walker)
- Clinically stable target hip
- No surgery planned in the target hip for at least 12 months following the last injection
- Completed general physical and well-being evaluation with primary care provider within 12 months of enrollment
- Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, and follow-up visits and assessments
- Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure
Who cannot join
- To be eligible for inclusion in this study, the subjects must not meet any of the following criteria:
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Congenital or acquired malformation of the target hip resulting in significant deformity or leading to problems with the study treatment or analysis of the results
- Significant structural deformity, including large cam lesion (alpha angle greater than 55 degrees) or moderate dysplasia (defined as lateral center edge angle less than 18 degrees).
- Injections of any kind into the target hip within 3 months prior to study enrollment
- Locking, catching, give-away or another major mechanical symptoms of the target hip
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- History of intra-articular infection in the target hip
- History of superficial infection in the target hip within 6 months of study enrollment, or evidence of current superficial infection affecting the target hip
- History of falls requiring medical attention, or gait instability
- Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results.
- Body mass index (BMI) > 35 kg/m2
- Taking anticoagulant medications (e.g. warfarin, heparin or clopidogrel) which may pose a clinically-significant contraindication to intra-articular injection.
- Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the study drug treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine and capsaicin)
- Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until at least 30 days following completion of the study drug treatment cycle
- Use of electrotherapy or acupuncture for OA, unless there is a stable regimen for at least 4 weeks before baseline assessment
- Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment
- On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids
- Current tobacco product use, including nicotine patch or other nicotine products
- Clinically significant systemic inflammatory, rheumatological or connective tissue disorder including but not limited to rheumatoid arthritis, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome
- Clinically significant rheumatological or inflammatory disease of the hip or chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the hip associated with juxta-articular Paget's disease of the femur or pelvis, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's hip joint, villonodular synovitis, and synovial chondromatosis
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis
- Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurologic (e.g. stroke, TIA) renal, hepatic, orthopedic (e.g. surgery on other weight bearing joints that will interfere with study, osteoporosis, acute lower body fractures), or endocrine disease (e.g. diabetes).
- Vascular or neurological disorder affecting the either lower limb which poses clinical significance to the safe delivery of intra-articular therapy.
- History of cancer/malignancy with the exception of adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target hip
- History of clinically significant blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy
- Participation in a study of an experimental drug or medical device within 3 months of study enrollment
- Known allergy to local anesthetics of other components of the study drug
- Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures
- History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 30 days of study entry
- Any illness or condition which, in the investigators' judgement will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: ASCLEPIOS Autologous Stem CelL Expansion and Prospective Injection for Osteoarthritic Hip Symptoms
Will injection(s) of autologous culture-expanded AMSCs be safe and efficacious for treatment of painful Hip OA, and if so, which dosing regimen is most effective?
Read the detailed description
This phase I study will enroll 24 subjects with mild to moderate osteoarthritis of the hip. Subjects will receive either a single dose of 30 million autologous culture-expanded adipose-derived mesenchymal stromal cells (AMSCs), or two doses of AMSCs (with one month interval between doses) via ultrasound guided intra-articular hip injection. Patients will be followed for 24 months past their last injection to determine the local and systemic safety of single and two-dose injections of AMSCs in the treatment of symptomatic hip OA.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Autologous Adipose Derived Mesenchymal Stromal Cells
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Derived Mesenchymal Stromal CellsDrug
Also called ASCLEPIOS
Human, autologous, culture expanded, adipose derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Human Cellular Therapy Laboratory using current good manufacturing practices
| Study group | Role | What they receive |
|---|---|---|
| Single Injection | Experimental | Single administration of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip by single ultrasound guided injection Receives: Drug: Autologous Adipose Derived Mesenchymal Stromal Cells |
| Two Injections | Experimental | Two-dose administration (2 x ultrasound guided injections) of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip with one month interval between doses Receives: Drug: Autologous Adipose Derived Mesenchymal Stromal Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature, incidence and severity of adverse events (AEs)
Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.
Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups
Measured: For a period of 2 years following last injection
Secondary outcomes (11)
Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles
100 mm Visual Analog Scale. Range: 0 to 100 mm. Lower is better, higher is worse.
Measured: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in Tegner activity scale in the target hip following completion of treatment cycles
Tegner activity scale (Level 0 to Level 10). Higher is better, lower is worse.
Measured: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in modified Harris Hip Score (mHHS) in the target hip following completion of treatment cycles
modified Harris Hip Score (mHHS). Score 0 to 100. Higher is better, lower is worse.
Measured: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in Hip disability and osteoarthritis Outcome Score (HOS) in the target hip following completion of treatment cycles
Hip disability and osteoarthritis Outcome Score (HOS). Score 0 to 100. Higher is better, lower is worse.
Measured: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in radiographic joint morphology
Evaluation of joint morphology on hip X-rays, including standing antero-posterior, lateral, and false profile
Measured: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage thickness
Cartilage thickness on MRI
Measured: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage volume
Cartilage volume on MRI
Measured: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage morphology
Cartilage morphology on MRI
Measured: Baseline, 6 months, and 12 months post-treatment cycle
Change in subchondral bone morphology
Subchondral bone morphology (i.e. edema) on MRI
Measured: Baseline, 6 months, and 12 months post-treatment cycle
Change periarticular soft-tissues
Evaluate periarticular tissues on MRI (i.e. visible synovitis)
Measured: Baseline, 6 months, and 12 months post-treatment cycle
Change in synovial fluid biomarkers within the target hip
Synovial fluid from attempted aspiration at the time of injection (and re-injection for the two injection cohort) will be analyzed for cells, cytokines, growth factors, and other similar biomarkers.
Measured: Baseline at the time of AMSC injection, At time of second injection (1 month status post first injection) in 2-injection group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start5 Nov 2018
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Krych, Mayo Clinic
- Investigators
- Aaron J Krych, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608579
- Sponsor's protocol ID
- 18-000015
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2018
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASCLEPIOS Autologous Stem CelL Expansion and Prospective Injection for Osteoarthritic Hip Symptoms
- ClinicalTrials.gov ID
- NCT03608579
- Acronym / sponsor ID
- 18-000015
- Conditions
- Osteoarthritis, Hip
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Will injection(s) of autologous culture-expanded AMSCs be safe and efficacious for treatment of painful Hip OA, and if so, which dosing regimen is most effective?
Detailed description
This phase I study will enroll 24 subjects with mild to moderate osteoarthritis of the hip. Subjects will receive either a single dose of 30 million autologous culture-expanded adipose-derived mesenchymal stromal cells (AMSCs), or two doses of AMSCs (with one month interval between doses) via ultrasound guided intra-articular hip injection. Patients will be followed for 24 months past their last injection to determine the local and systemic safety of single and two-dose injections of AMSCs in the treatment of symptomatic hip OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Injection | Experimental | Drug: Autologous Adipose Derived Mesenchymal Stromal CellsSingle administration of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip by single ultrasound guided injection |
| Two Injections | Experimental | Drug: Autologous Adipose Derived Mesenchymal Stromal CellsTwo-dose administration (2 x ultrasound guided injections) of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip with one month interval between doses |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
- Male or female ages 18-65 years
- Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded.
- Chronic (> 3 months), unilaterally symptomatic, primary hip OA. Patients with episodes of contralateral hip pain that is asymptomatic at the time of enrollment will be eligible for inclusion. However, as outlined in the primary study endpoints, patients with previous episodes of contralateral hip pain who experience a repeat episode of contralateral pain similar to their established pattern of pain during the course of the trial will not be considered as having experienced an adverse event.
- Radiographic hip OA of Tönnis Grade 1 - 2, accompanied by at least mild sclerosis and joint space narrowing, as agreed upon by two study co-investigators without underlying structural hip abnormalities
Key exclusion criteria (30 listed)
- To be eligible for inclusion in this study, the subjects must not meet any of the following criteria:
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Congenital or acquired malformation of the target hip resulting in significant deformity or leading to problems with the study treatment or analysis of the results
- Significant structural deformity, including large cam lesion (alpha angle greater than 55 degrees) or moderate dysplasia (defined as lateral center edge angle less than 18 degrees).
- Injections of any kind into the target hip within 3 months prior to study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Adipose Derived Mesenchymal Stromal CellsAlso: ASCLEPIOSHuman, autologous, culture expanded, adipose derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Human Cellular Therapy Laboratory using current good manufacturing practices | Drug | Single Injection, Two Injections |
Primary outcome
Nature, incidence and severity of adverse events (AEs)
Time frame: For a period of 2 years following last injection
Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship. Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups
11 secondary outcomes
Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles
Time frame: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in Tegner activity scale in the target hip following completion of treatment cycles
Time frame: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in modified Harris Hip Score (mHHS) in the target hip following completion of treatment cycles
Time frame: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in Hip disability and osteoarthritis Outcome Score (HOS) in the target hip following completion of treatment cycles
Time frame: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in radiographic joint morphology
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage thickness
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage volume
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage morphology
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in subchondral bone morphology
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change periarticular soft-tissues
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in synovial fluid biomarkers within the target hip
Time frame: Baseline at the time of AMSC injection, At time of second injection (1 month status post first injection) in 2-injection group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron J Krych principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Adipose Derived Mesenchymal Stromal Cells in people with Osteoarthritis, Hip, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature, incidence and severity of adverse events (AEs) (time frame: For a period of 2 years following last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.