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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
Must not have
On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state
Injections of any kind into the target knee within 3 months prior to study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial tests a new treatment for severe knee cartilage damage using stem cells from fat tissue and the patient's own cartilage cells. The mixture is applied to the damaged area to help repair it. These methods are being pursued as alternatives for cartilage repair.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on long-term medication to suppress my immune system.
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I haven't had injections in my knee in the last 3 months.
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My knee is significantly misaligned and not corrected before surgery.
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I have had falls needing medical help or have trouble walking steadily.
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I am taking NSAIDs without a consistent dose.
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I have a significant inflammatory, rheumatological or connective tissue condition.
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My knee is deformed due to a birth defect or injury.
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I am currently taking blood thinner medications.
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I have had an infection inside my knee joint.

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

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)

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REcycled CartiLage Auto/Allo IMplantation
2018
Completed Phase 1
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for cartilage defects, such as the use of allogeneic culture-expanded adipose-derived mesenchymal stem cells (AMSCs) combined with autologous cartilage cells, work by promoting the repair and regeneration of damaged cartilage. MSCs have the ability to differentiate into chondrocytes, the cells responsible for cartilage formation, and secrete bioactive molecules that reduce inflammation and stimulate tissue repair. Autologous cartilage cells, harvested from the patient, are used to ensure compatibility and enhance the integration of new tissue. This combination therapy aims to restore the structural integrity and function of the cartilage, which is crucial for patients as it can alleviate pain, improve joint function, and potentially delay or prevent the need for more invasive procedures like joint replacement.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,420 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
~4 spots leftby Sep 2025
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