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

NCT06798623 | Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro00039160
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Incidence of Treatment-Emergent Adverse Events

  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.

  4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop

• Knee Function

  Knee function will be assessed through patient reported responses on the Knee Injury and Osteoarthritis Outcome Score (KOOS) survey via REDCap. The Questionnaire has five subscales which are separately scored (pain, function in daily living, function in sport and recreation, other symptoms and knee-related quality of life). Final score will be determined on a scale of 0-100 where 100 indicates no symptoms and 0 indicates extreme symptoms.

  Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop

• Knee Function

  Function will be assessed with the International Knee Documentation Committee Subjective Knee Form (IKDC) which contains sections on knee symptoms, function, and sports activities. 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).

  Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop

• Knee Function

  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.

  Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop

Secondary Outcomes (4)

• Knee Pain

  Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop

• Return to Sport Time

  3 months postop

• Knee Swelling

  Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop

• Knee Pain

  Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop

Study Arms (1)

Intra-articular injection of autologous mesenchymal stromal cells

EXPERIMENTAL

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.

Biological: Autologous Mesenchymal Stromal Cells

Interventions

Autologous Mesenchymal Stromal Cells 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.

Intra-articular injection of autologous mesenchymal stromal cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with bone-to-bone (BTB) patellar tendon autograft with the Principal Investigator (PI).
• Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.

You may not qualify if:

• Under 18 years of age
• Prior surgery on affected knee
• Diabetes
• 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
• Any other medical condition that in the opinion of the primary investigator would constitute a relative contraindication to study participation (e.g., Ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, SLE, scleroderma, polymyositis, Ehlers-Danlos syndrome, osteoporosis)

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Patrick McCulloch, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison Bowden

CONTACT

713-363-7390; mmbowden@houstonmethodist.org

Haley Goble

CONTACT

713-441-3930; hmgoble@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John S. Dunn Chair in Orthopedic Surgery

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 29, 2025
• Study Start: March 24, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)