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Stem Cell Therapy

Cartilage Cell + Stem Cell Implantation for Knee Cartilage Repair

Phase 1
Waitlist Available
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
At least 3 months since the last target knee intraarticular injection prior to undergoing RECLAIM therapy
Clinically stable target knee
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trialwill test if a combo of stem cells and cartilage cells is safe for knee cartilage repair in a single surgery.

Who is the study for?
Adults aged 18-50 with chronic knee cartilage damage, who've tried other treatments like physical therapy or injections without success. They must be able to walk unaided and not have had recent knee surgery or injections. Women of childbearing age need a negative pregnancy test and must use contraception.Check my eligibility
What is being tested?
The trial is testing a one-stage surgical treatment combining donor stem cells with the patient's own cartilage cells for repairing knee cartilage defects. It aims to see if this approach is safe for patients with specific types of knee injuries.See study design
What are the potential side effects?
As this is a phase I study primarily assessing safety, potential side effects are not detailed but may include typical risks associated with surgical procedures such as infection, bleeding, pain at the injection site, and possible immune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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It has been over 3 months since my last knee injection.
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My knee's condition is stable.
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I have a long-term knee cartilage injury that's been painful for over 3 months.
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I can walk on my own without help.
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I am between 18 and 50 years old.
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My knee arthritis is mild, based on X-ray results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nature, incidence and severity of adverse events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: RECLAIMExperimental Treatment1 Intervention
Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,759 Total Patients Enrolled
Aaron J KrychPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
274 Total Patients Enrolled

Media Library

REcycled CartiLage Auto/Allo IMplantation (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03672825 — Phase 1
REcycled CartiLage Auto/Allo IMplantation (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03672825 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned REcycled CartiLage Auto/Allo IMplantation?

"Due to the limited data regarding safety and efficacy for REcycled CartiLage Auto/Allo IMplantation, our team at Power assigned it a score of 1."

Answered by AI

Do the eligibility requirements of this experiment extend to individuals aged eighty and above?

"In order to participate in this trial, the patient must be between 18 and 50 years old."

Answered by AI

Is it feasible for me to become involved in this trial?

"This clinical trial is recruiting 25 individuals, aged 18-50 years old, with cartilage defects. To be eligible for admission to this study, one must have previously tried conservative treatments such as activity modification or weight loss; women of childbearing potential must provide a negative pregnancy result before receiving the medication and use effective contraception methods until two years post treatment. Additionally, participants need ICRS Grade III/IV cartilage lesions between 2 and 8 cm2 in size that has not been treated by surgery within 12 months; they should also possess radiograph KLG grade 1 or less and able to walk without assistance regularly."

Answered by AI

Are any new participants being sought for this research endeavor?

"Data posted on clinicaltrials.gov informs us that this particular medical study is no longer recruiting patients; the trial was initially listed in 13th September 2018 and last updated 2nd December 2022. Although, there are two other trials actively looking for participants right now."

Answered by AI
~1 spots leftby Sep 2024