Mesenchymal Stem Cells for ACL Reconstruction

Overseen By Madison Bowden

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Diabetes, Heart disease, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using mesenchymal stromal cells (also known as mesenchymal stem cells) to determine their safety and effectiveness for individuals undergoing ACL reconstruction. The treatment involves a single injection of these cells during ACL surgery to potentially enhance healing. It suits those scheduled for ACL surgery who plan to complete their post-surgery physical therapy at a Houston Methodist clinic. Participants should not have had previous knee surgeries, diabetes, or other conditions that might interfere with recovery. As a Phase 1 trial, participants will be among the first to receive this innovative treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using a person's own cells, known as autologous mesenchymal stromal cells (MSCs), is generally safe in joint treatment studies. One study found that a single injection of these cells was safe and caused no serious side effects. These cells, sourced from the patient's own body, have shown promise in repairing tissues like tendons and ligaments, including those in the knee. Although further research is necessary to fully confirm their safety, early results are encouraging for their use in ACL (anterior cruciate ligament) reconstruction. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using autologous mesenchymal stromal cells (MSCs) for ACL reconstruction because they offer a new approach to healing. Unlike traditional treatments like surgical grafts, which primarily focus on mechanically repairing the ligament, MSCs are derived from the patient's own infrapatellar fat pad and are injected directly into the joint. This treatment harnesses the body's natural healing processes, potentially speeding up recovery and improving tissue regeneration. The use of MSCs could lead to better long-term outcomes by reducing the risk of re-injury and enhancing the quality of the repaired tissue.

What evidence suggests that this treatment might be an effective treatment for ACL reconstruction?

Research shows that certain cells, called mesenchymal stromal cells (MSCs), might aid in healing injuries to the anterior cruciate ligament (ACL). Animal studies have found that these cells improve ligament repair by enhancing tissue healing. In this trial, participants will receive an intra-articular injection of autologous mesenchymal stromal cells derived from their own infrapatellar fat pad during ACL reconstruction surgery. MSCs are believed to support the body's natural healing. Although research in humans is ongoing, initial results are encouraging. Scientists are exploring whether MSCs can make ACL reconstruction more effective by promoting faster and stronger recovery. ^{1 5 6 7 8}

Who Is on the Research Team?

Patrick McCulloch, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals undergoing ACL reconstruction surgery and who will receive post-surgery physical therapy at a Houston Methodist PT clinic. It's not specified who can't join, but typically there would be criteria excluding certain patients.

Inclusion Criteria

I am getting physical therapy at a Houston Methodist PT clinic after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Injection

Participants undergo ACL reconstruction surgery and receive an intra-articular injection of autologous mesenchymal stromal cells

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for adverse events and knee function through follow-up visits

6 months

4 visits (in-person) at 4-5 weeks, 6-7 weeks, 3.5 months, and 6 months postop

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Mesenchymal Stromal Cells

Trial Overview The study tests the safety and effectiveness of injecting mesenchymal stromal cells derived from the patient's own fat pad into their knee joint after ACL surgery to see if it helps with healing.

How Is the Trial Designed?

Group I: Intra-articular injection of autologous mesenchymal stromal cells Experimental Treatment 1 Intervention

Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06798623

Study Details | NCT06798623 | Anterior Cruciate Ligament ... Autologous mesenchymal stromal/stem cells extracted from the subject during a routine standard of care ACL reconstruction surgery and reintroduced in one clinic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8352687/

Application of Stem Cell Therapy for ACL Graft Regeneration Recent scientific literature has demonstrated promising outcomes of stem cell augmentation for ligament reconstruction in animal models [41–43] ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S221262871930146X

Stem Cell–Infused Anterior Cruciate Ligament ... In this technical note and accompanying video, we describe an anatomic allograft ACL reconstruction infused with BMAC to utilize BMAC's potential benefits.

4. aoj.amegroups.org aoj.amegroups.org/article/view/3934/html

Stem cell-based therapy in anterior cruciate ligament repair This review describes the current understanding of capacity of ACL healing and summarizes the current status of related stem cell therapy.

5. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(22)00706-X/fulltext

Biologics, Stem Cells, Growth Factors, Platelet-Rich ... Biologics including mesenchymal stem cells (MSCs), growth factors, and platelet-rich plasma may enhance anterior cruciate ligament (ACL) reconstruction and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2352320417300470

Anterior cruciate ligament-derived mesenchymal stromal ... Currently, ACL reconstruction using autologous tendons is the predominant method for ACL repair, with a fairly good recovery score [7]. Nevertheless, to avoid ...

7. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-017-1391-0

Safety, tolerability, clinical, and joint structural outcomes of a ... The objectives of this pilot study were to determine the safety and tolerability and to explore the efficacy of a single intra-articular ...

8. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/140716-molecular-biology-of-acl-graft-healing-early-mechanical-loading-perspective

Molecular Biology of ACL Graft Healing: Early Mechanical ... BMP12 and BMP13 gene transfer induce ligamentogenic differentiation in mesenchymal progenitor and anterior cruciate ligament cells.