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Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Anterior Cruciate Ligament Reconstruction

NCT04650568 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-07

No results posted yet for this study

Summary

This study will evaluate the efficacy of biologic augmentation of ACL reconstruction with bone marrow derived mesenchymal stem cells as measured by magnetic resonance imaging to detect graft healing and integration. Secondary endpoints will include validated patient reported outcome measures, as well as functional outcome using objective examination findings.

Conditions

  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Rupture

Interventions

DEVICE

Autologous Bone Marrow Derived Mesenchymal Stem Cells

Autologous Bone Marrow Derived Mesenchymal Stem Cells injected into the ACL allograft prior to graft implantation.

OTHER

Sham incision

Small incision over the site where bone marrow aspirate would have been obtained

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2026-05-03
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04650568 on ClinicalTrials.gov