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Cell Therapy
Cartilage Cell + Stem Cell Therapy for Cartilage Defects
Phase 1
Recruiting
Led By Aaron Krych, MD
Research Sponsored by Daniel B. F. Saris
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a combination of a person's own cartilage cells and allogeneic adipose-derived mesenchymal stem cells, mixed in fibrin glue, is safe and has manageable side effects when used to treat cartilage defects.
Who is the study for?
This trial is for adults with specific hip cartilage defects, who can walk unassisted and have tried other treatments without success. They must not be pregnant or planning pregnancy, have a BMI under 35, no recent infections in the target hip, stable health without significant diseases like heart conditions or diabetes, and no history of certain blood disorders or cancer.
What is being tested?
The study tests a new treatment where patients' own cartilage cells are mixed with donor fat-derived stem cells and a special glue to repair damaged hip cartilage. The goal is to see if this mix is safe and what side effects it might cause when used to treat cartilage defects in the hip.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, infection risks due to surgery, allergic reactions to any of the components used (like fibrin glue), and general surgical risks like bleeding or clotting issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Adverse Events
Incidence of serious adverse events (SAEs)
Secondary study objectives
Change in hip function
Change in pain
Change in physical function
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CartiLage Auto/Allo IMplantation for Focal Hip Cartilage DefectsExperimental Treatment1 Intervention
Subject will receive the combined product of autologous cartilage cells and allogeneic AMSCs in a fibrin glue carrier.
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Who is running the clinical trial?
Daniel B. F. SarisLead Sponsor
Aaron Krych, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart, brain, kidney, liver, bone, or hormone-related disease.I have had falls needing medical help or have trouble walking.My hip has a significant deformity due to a birth defect or other condition.I have a serious hip condition causing inflammation or pain.I am currently taking blood thinner medications.I am taking NSAIDs without a consistent dose.I have a history of blood clotting disorders.I have a long-term knee cartilage injury that's been painful for over 3 months.My hip condition is stable.My hip arthritis is mild according to X-ray results.I had a minor infection in my hip less than 6 months ago.It has been over 6 months since my last hip surgery.I had a full health check-up in the last year.I am currently fighting an infection.I have had cancer before, but it was either basal cell or squamous cell skin cancer and was treated successfully.I have a history of serious blood disorders.I am on long-term medication to suppress my immune system after a transplant.I have a blood vessel or nerve condition in my leg.I haven't had injections in my hip for the last 3 months.I can walk on my own without help.I have a health condition that could affect my ability to have surgery.I have not taken any herbal therapies or supplements in the last 4 weeks.It has been over 3 months since my last hip injection.I have no health issues that would stop me from following the study's requirements.I don't plan to have more hip surgery for a year after the RECLAIM procedure.
Research Study Groups:
This trial has the following groups:- Group 1: CartiLage Auto/Allo IMplantation for Focal Hip Cartilage Defects
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.