Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for patients undergoing surgery to reconstruct their anterior cruciate ligament (ACL), a crucial ligament in the knee. The study aims to test the safety and effectiveness of using special cells called mesenchymal stem cells, which are taken from a small piece of fat in the knee, to help with recovery. Each participant will receive a single injection of these stem cells during their surgery, followed by physical therapy to aid in their healing process.

To be eligible for this trial, participants must be at least 18 years old and scheduled for ACL reconstruction surgery. They should also be willing to attend physical therapy sessions at a specific clinic. However, there are certain conditions that may exclude individuals from participating, such as having had previous knee surgery, certain health issues like diabetes or heart disease, and being pregnant. If you or a loved one meet the criteria and are interested in this innovative approach to recovery, this trial could offer a new option to enhance healing after ACL surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with the Principal Investigator (PI).
• • Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.
• Exclusion Criteria:
• • Under 18 years of age
• • Prior surgery on affected knee
• • Diabetes
• • Root repair, inflammatory arthropathy, or any other concomitant procedure that cannot follow an accelerated PT protocol or any concomitant procedure that the PI deems exclusionary
• • Unable to attend physical therapy at Houston Methodist
• • Vulnerable populations
• • Immunocompromised patients such as those being treated for cancer, kidney failure, etc.
• • Heart disease including (systolic blood pressure \>180 mm Hg or heart failure)
• • Active infections
• • Non-English-speaking patients
• • Any known metal implants or allergy to contrast agents
• • Pregnancy (as part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative result is required to proceed with surgery per SOC and thus, participate in the study) and those planning to become pregnant during the duration of the study
• • Any condition with known bleeding disorders, thrombus formation risk factors, or overlying wound and skin infections
• • Any condition in the opinion of the primary investigator that would compromise the integrity of the data collection or outcomes being assessed