Back to search results

ACL Reconstruction with Autologous Fat Pad Derived Mesenchymal Stem Cells

This study is looking at the safety and effectiveness of using your own mesenchymal stromal cells (special cells that can develop into different cell types) to help with Anterior Cruciate Ligament (ACL) reconstruction. If you're having ACL reconstruction surgery using a patellar tendon graft and are 18 or older, you might be able to join. During your surgery, cells will be taken from your fat pad and then injected back into your knee about 21 days later. Researchers will check for any side effects and measure your knee function to see how well the treatment works. This is a small pilot study aiming to enroll 15 participants, but its current status is unclear.

Study design
This is a small, open-label pilot study with 15 participants, meaning everyone receives the same treatment and researchers know what treatment is given.
What's involved
You would undergo ACL reconstruction surgery, have cells collected during surgery, and receive an injection of these cells about 21 days later. You'll also need to attend follow-up appointments for physical therapy at a Houston Methodist clinic.
Compensation
Not stated in the trial record.
Follow-up
Your knee function and any side effects will be monitored at 4-5 weeks, 6-7 weeks, 3.5 months, and 6 months after your surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06798623

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
The Methodist Hospital Research Institute
~15 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Autologous Mesenchymal Stromal Cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events
Measured over 4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop
+3 more outcomes measured

Conditions

Anterior Cruciate Ligament Reconstruction

Explore related trials

Injury of anterior cruciate ligament

NCT06798623

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Houston Methodist Hospital

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Patrick McCulloch, MD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

Who to contact

Madison Bowden
[email protected]
713-363-7390
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

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
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)

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events4-5 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 FunctionPreoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop

    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.

  • Knee FunctionPreoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop

    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).

  • Knee FunctionPreoperative 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.