Mesenchymal Stem Cells for ACL Reconstruction

Overseen By David Armond

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 study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. 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 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+