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Cartilage Cell + Stem Cell Therapy for Cartilage Defects
Study 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.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: CartiLage Auto/Allo IMplantation for Focal Hip Cartilage Defects
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What criteria must an individual meet in order to be eligible for this scientific experiment?
"This clinical trial is accepting 15 participants of ages 18-50 with cartilage damage. A few key prerequisites include a negative pregnancy test for persons of childbearing potential, Tönnis Grade 1 or less radiographic hip OA, at least 6 months have passed since the last target hip intraarticular injection and 12 months since any prior arthroscopic/open hip procedures, clinically stable target hip, 3 month+ previous conservative treatment course (activity modification etc.) with minimal to no improvements in symptoms, ability to walk without assistance."
Are there any openings for this clinical endeavor at the present time?
"According to the information hosted on clinicaltrials.gov, this trial is actively seeking participants. It was first advertised on December 1st 2022 and its details were most recently modified on November 21st of that same year."
Does the protocol for this experiment include individuals over twenty years of age?
"This clinical trial seeks patients between the ages of 18 and 50."
Has the FDA approved Cartilage Auto/Allo Implantation for Focal Hip Cartilage Defects?
"Our team has assigned a score of 1 to CartiLage Auto/Allo IMplantation for Focal Hip Cartilage Defects as it is currently in the first stage of trials and there are limited clinical data available to suggest safety or efficacy."
What is the recruitment target for this research trial?
"Affirmative. Records hosted on clinicaltrials.gov demonstrate that this medical experiment, which was initially posted on December 1st 2022, is actively soliciting participants. 15 individuals must be sourced from a single site."
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