Adipose Derived MSCs for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen byAaron J Krych

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?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?

Eligibility Criteria

This trial is for adults aged 18-65 with chronic hip osteoarthritis (OA) pain, who've tried conservative treatments without surgery plans for the next year. Participants must be able to walk unassisted and agree to use contraception if of childbearing potential. Exclusions include pregnancy, allergies to study drugs, recent injections in the target hip, BMI over 35, certain medication use, infectious diseases like HIV or hepatitis, history of cancer except some skin cancers, drug abuse or significant cardiovascular and other systemic diseases.

Inclusion Criteria

At least 12 months must go by after the last injection before surgery is planned in the target hip.

Completed general physical and well-being evaluation with their primary care provider within the past 12 months.

• 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

+10 more

Exclusion Criteria

You have a condition in your blood vessels or nerves that affects your lower limbs and could make it unsafe to receive treatment directly in your joints.

Pregnant or nursing, or planning on becoming pregnant during the study period

You are allergic to the numbing medicine or other ingredients in the study drug.

+26 more

Participant Groups

The trial tests whether injecting a patient's own cultured adipose-derived mesenchymal stromal cells (AMSCs) into their painful hip can safely relieve OA pain and which dose works best. It involves fat harvesting from participants followed by laboratory cell expansion before injection back into the affected hip joint.

2Treatment groups

Experimental Treatment

Group I: Two InjectionsExperimental Treatment1 Intervention

Two-dose administration (2 x ultrasound guided injections) of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip with one month interval between doses

Group II: Single InjectionExperimental Treatment1 Intervention

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