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

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Enrolling; Phase 1

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Biological: Autologous Mesenchymal Stromal Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT06798623

Pro00039160

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intra-articular injection of autologous mesenchymal stromal cells

Experimental group

Description:

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.

Treatment:

Biological: Autologous Mesenchymal Stromal Cells