Actively Recruiting
Anterior Cruciate Ligament Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
Led by The Methodist Hospital Research Institute · Updated on 2026-04-16
15
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
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 patient's 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 study's 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
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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo anterior cruciate ligament (ACL) reconstruction surgery with bone-to-bone patellar tendon autograft and infrapatellar fat pad tissue collection for stem cell preparation.
1 surgery visit (in-person)
Duration - Single treatment visit approximately 3 weeks post-surgery
Participants receive one intra-articular injection of autologous mesenchymal stromal cells approximately 21 days after surgery.
1 injection visit (in-person)
Duration - Up to 6 months post-surgery
Participants attend follow-up visits to monitor safety, knee function, pain, swelling, and return to sport over six months after surgery and treatment.
Visits at 4-5 weeks, 6-7 weeks, 3 months, 3.5 months, and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Madison Bowden
H
Haley Goble
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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