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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ for a period of 2 years following last injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for a period of 2 years following last injection
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 moreAwards & 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
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,344 Previous Clinical Trials
3,062,379 Total Patients Enrolled
32 Trials studying Osteoarthritis
3,111 Patients Enrolled for Osteoarthritis
Aaron J KrychPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
275 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.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.You are allergic to the numbing medicine or other ingredients in the study drug.You have a serious health condition related to inflammation or problems with your joints, muscles, or connective tissues.You have been using electrotherapy or acupuncture for osteoarthritis, but you need to have a consistent treatment plan for at least 4 weeks before the study begins.You have significant problems with your hip joint, like it getting stuck, catching, or feeling unstable.You are currently taking medications that prevent blood clotting, which may not be safe for the injection procedure.You have had a previous infection in the hip that we are studying.If you become pregnant during the study, you will be monitored until the end of the study or until you deliver, whichever is longerYour hip is in a stable condition and not causing any problems.You have been taking herbal therapies or supplements within the last 4 weeks, or you are not willing to stop taking them until at least 30 days after finishing the study treatment. This includes things like chondroitin sulfate, diacerein, glucosamine, and capsaicin.You are currently using any form of tobacco products, including nicotine patches or other nicotine products.You have a history of or are currently struggling with alcohol or drug addiction, including recreational use of illegal drugs or prescription medications. You have also used medical marijuana within the past 30 days.You have a history of falling and needing medical treatment, or you have difficulty walking steadily.The study is for males or females aged 18-65 years.You have had a unilateral hip pain that has lasted for at least 3 months and is causing significant pain or limitation of activity.You have had serious heart, brain, kidney, liver, bone, or hormone-related conditions that could affect your ability to participate in the study.You have a hip deformity that could affect the study treatment or analyzing the results.You have significant hip-related or inflammatory diseases, such as arthritis, joint infections, or certain rare conditions affecting the hip joint.
Research Study Groups:
This trial has the following groups:- Group 1: Single Injection
- Group 2: Two Injections
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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