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

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06798623
Phase
PHASE1
Status
Recruiting
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Conditions

  • Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 24, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intra-articular injection of 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 Measure

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Madison Bowden
[email protected]
713-363-7390

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By research site
Houston Methodist Hospital· Houston, TX

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