Autologous Culture Expanded Adipose Derived MSCs for Treatment of Painful Hip OA

NCT03608579 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 18-000015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Baseline, 6 weeks, 6 months, 12 months post-treatment cycle

• Change in Tegner activity scale in the target hip following completion of treatment cycles

  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

  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

  Baseline, 6 weeks, 6 months, 12 months post-treatment cycle

• Change in radiographic joint morphology

  Baseline, 6 months, and 12 months post-treatment cycle

Study Arms (2)

Single Injection

EXPERIMENTAL

Single administration of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip by single ultrasound guided injection

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

Drug: Autologous Adipose Derived Mesenchymal Stromal Cells

Interventions

Autologous Adipose Derived Mesenchymal Stromal Cells DRUG

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

Also known as: ASCLEPIOS

Single Injection; Two Injections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Aaron J Krych

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedics

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 1, 2018
• Study Start: November 5, 2018
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)