Recruiting
Phase 1

Mesenchymal Stromal Cells

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06798623

Conditions

Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autologous Mesenchymal Stromal Cells

Study Details

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

Study ID

NCT06798623

Start date

Mar 24, 2026

Status verified date

Mar, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Autologous Mesenchymal Stromal Cells

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.

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 ]
  • Knee Function [ Time Frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop ]
  • Knee Function [ Time Frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop ]
  • Knee Function [ Time Frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop ]

Central Contacts and Locations

Central contacts

Madison Bowden

713-363-7390mmbowden@houstonmethodist.org

Haley Goble

713-441-3930hmgoble@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Madison Bowden

713-363-7390mmbowden@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Apr 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-04-16.