What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common side effects of treatments for cartilage defects, particularly those involving mesenchymal stem cells (MSCs) and autologous cartilage cells, include local inflammation, pain at the injection or surgical site, risk of infection, and potential immune reactions. Surgical procedures may also carry risks such as bleeding and damage to surrounding tissues.

What prior FDA approvals exist?

The FDA has approved several treatments for cartilage defects, including autologous chondrocyte implantation (ACI) and matrix-induced autologous chondrocyte implantation (MACI). These treatments involve harvesting a patient's own cartilage cells, expanding them in a lab, and re-implanting them into the cartilage defect. While there is ongoing research into the use of allogeneic culture-expanded adipose-derived mesenchymal stem cells (AMSCs) combined with autologous cartilage cells, specific FDA approvals for this exact combination are not yet established. However, the regenerative approach aligns with the broader trend of using stem cell-based therapies for cartilage repair.

What other types of research exist?

Promising novel alternatives for cartilage defects include: <ol> <li>Intraarticular sprifermin (recombinant human fibroblast growth factor 18), which has shown potential in stimulating chondrogenesis and cartilage repair.</li> <li></li> </ol> Bone marrow-derived mesenchymal stem cells (MSCs), which have demonstrated improved outcomes in tendon repair and may have applications in cartilage repair. 3. Gene therapy approaches, such as those using induced pluripotent stem cells (iPSCs) to generate cartilage cells for transplantation.

← Back to Search

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

No Placebo-Only Group

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

Select...

It has been over 3 months since my last knee injection.

Select...

My knee's condition is stable.

Select...

I have a long-term knee cartilage injury that's been painful for over 3 months.

Select...

I can walk on my own without help.

Select...

I am between 18 and 50 years old.

Select...

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:

Select...

I am on long-term medication to suppress my immune system.

Select...

I haven't had injections in my knee in the last 3 months.

Select...

My knee is significantly misaligned and not corrected before surgery.

Select...

I have had falls needing medical help or have trouble walking steadily.

Select...

I am taking NSAIDs without a consistent dose.

Select...

I have a significant inflammatory, rheumatological or connective tissue condition.

Select...

My knee is deformed due to a birth defect or injury.

Select...

I am currently taking blood thinner medications.

Select...

I have had an infection inside my knee joint.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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)

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: 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

0 / 15Eligibility criteria met

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.