What is this study investigating for anterior cruciate ligament reconstruction?

This study is investigating the safety and effects of a single injection of mesenchymal stromal cells taken from a patient's own fat tissue during ACL reconstruction surgery. The research aims to understand how these cells might impact recovery and knee function after surgery. The Methodist Hospital Research Institute is leading this clinical trial.

Who may be eligible for this anterior cruciate ligament reconstruction clinical trial?

Adults 18 years or older scheduled for ACL reconstruction using a bone-to-bone patellar tendon autograft and able to attend physical therapy at Houston Methodist may be eligible. People with prior surgery on the affected knee, diabetes, or certain medical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this anterior cruciate ligament reconstruction clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID06798623

Phase 1 Study of ACL Reconstruction Using Patients Own Fat Pad Derived Stem Cells Single Injection of Autologous Mesenchymal Stromal Cells to Improve Knee Healing

Led by The Methodist Hospital Research Institute · Updated on 2026-04-16

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a single injection of mesenchymal stromal cells taken from a patients own infrapatellar fat pad during anterior cruciate ligament ACL reconstruction surgery. This pilot clinical study is designed as a prospective, open-label, single-arm trial focusing on patients undergoing ACL reconstruction with a patellar tendon autograft. The study seeks to understand how these cells may impact recovery following surgery. Each participant will receive one intra-articular injection of autologous mesenchymal stromal cells about 21 days after their ACL reconstruction surgery. These cells are collected during the surgery, cultured, modified, and prepared to contain 50 million cells in a 1.5 ml dose. This treatment is administered in a single clinic visit following the surgical procedure. Participants will be monitored through several follow-up visits up to 6 months after surgery. Assessments include tracking treatment-related adverse events, knee function, pain, swelling, and time taken to return to sports activities. Evaluations occur preoperatively and at 6 weeks, 3.5 months, and 6 months postoperatively to measure the studys outcomes and monitor safety throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

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 will not qualify if you...

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 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)

Research Team

Madison Bowden

Haley Goble

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