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Mesenchymal Stromal Cells

Adipose Derived MSCs for Osteoarthritis

Phase 1
Recruiting
Led By Aaron J Krych
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for a period of 2 years following last injection
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a certain type of injection is safe and effective for treating hip pain caused by arthritis.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, infection risk due to invasive procedures involved in fat harvesting and injections. There might also be general risks associated with cell therapies including immune system reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for a period of 2 years following last injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and for a period of 2 years following last injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nature, incidence and severity of adverse events (AEs)
Secondary study objectives
Change in Hip disability and osteoarthritis Outcome Score (HOS) in the target hip following completion of treatment cycles
Change in Tegner activity scale in the target hip following completion of treatment cycles
Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,148 Total Patients Enrolled
31 Trials studying Osteoarthritis
3,091 Patients Enrolled for Osteoarthritis
Aaron J KrychPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
275 Total Patients Enrolled

Media Library

Autologous Adipose Derived Mesenchymal Stromal Cells (Mesenchymal Stromal Cells) Clinical Trial Eligibility Overview. Trial Name: NCT03608579 — Phase 1
Osteoarthritis Research Study Groups: Single Injection, Two Injections
Osteoarthritis Clinical Trial 2023: Autologous Adipose Derived Mesenchymal Stromal Cells Highlights & Side Effects. Trial Name: NCT03608579 — Phase 1
Autologous Adipose Derived Mesenchymal Stromal Cells (Mesenchymal Stromal Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03608579 — Phase 1
~3 spots leftby Nov 2025