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

NCT ID: NCT06798623

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2030-03-31

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-articular injection of autologous mesenchymal stromal cells

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.

Group Type: EXPERIMENTAL

Autologous Mesenchymal Stromal Cells

Intervention Type: BIOLOGICAL

Autologous mesenchymal stromal/stem cells extracted from the subject during a routine standard of care ACL reconstruction surgery and reintroduced in one clinic visit approximately 21 days after completion of the surgery. After being removed from the patient, the cells will be cultured, modified, and harvested to become the final investigational product. Each subject will receive 1.5 ml of the investigative drug. This will contain 5x10\^7 (50 million) autologous MSCs.

Interventions

Autologous Mesenchymal Stromal Cells

Autologous mesenchymal stromal/stem cells extracted from the subject during a routine standard of care ACL reconstruction surgery and reintroduced in one clinic visit approximately 21 days after completion of the surgery. After being removed from the patient, the cells will be cultured, modified, and harvested to become the final investigational product. Each subject will receive 1.5 ml of the investigative drug. This will contain 5x10\^7 (50 million) autologous MSCs.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Patrick McCulloch,MD

John S. Dunn Chair in Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick McCulloch, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Madison Bowden

Role: CONTACT

mmbowden@houstonmethodist.org

713-363-7390

Haley Goble

Role: CONTACT

hmgoble@houstonmethodist.org

713-441-3930

Facility Contacts

Madison Bowden

Role: primary

mmbowden@houstonmethodist.org

713-363-7390

Other Identifiers

Pro00039160

Identifier Type: -

Identifier Source: org_study_id