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

Phase 1

Not yet recruiting

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Biological: Autologous Mesenchymal Stromal Cells

• Registration Number: NCT06798623
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Study Start: 2025-06
• Primary Completion: 2028-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-articular injection of autologous mesenchymal stromal cells	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop	Participants will be asked via a follow-up phone call following injection whether or not they have experienced any adverse events following the injection. They will be assessed at all remaining standard of care follow up visits and staff will inquire about adverse events.
Knee Function	Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop	Active and passive Range of Motion (ROM) of the operated and contralateral knee will be documented by the physician. This will be determined by the measurement of angles in each plane at the body's joints.

Secondary Outcome Measures

Name	Time	Method
Knee Pain	Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop	Questions related to pain will also be assessed on the International Knee Documentation Committee Subjective Knee Form (IKDC), although this is not its primary focus. Total score will range from 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Return to Sport Time	3 months postop	Return to sport time will be evaluated via the subject's standard of care (SOC) physical therapy notes in their chart.
Knee Swelling	Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop	The trans-patellar circumference of both knees will be measured at the standard of care (SOC) appointments the subject will attend throughout the study to monitor swelling. Knees will be measured utilizing a flexible measuring tape and the affected knee will be compared to the unaffected knee to verify the difference in size, and therefore the severity of swelling. The greater the difference in size between knees, the more severe the swelling.