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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT04650568
Status
Enrolling By Invitation

Conditions

  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Rupture

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Bone Marrow Derived Mesenchymal Stem Cells — DEVICE
    Autologous Bone Marrow Derived Mesenchymal Stem Cells injected into the ACL allograft prior to graft implantation.
  • Sham incision — OTHER
    Small incision over the site where bone marrow aspirate would have been obtained

Study Details

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.

Key Dates

Start date
Nov 3, 2017
Status verified
Jan 2026
Primary completion
May 3, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mesenchymal Stem Cell Recipient
    Patients in this group will receive between 1-4 ml of bone marrow aspirate concentrate (BMAC) containing mesenchymal stem cells (MSCs) obtained from their iliac crest. A small incision will be made on the anterior superior iliac spine in order to withdraw the aspirate. The aspirate will be ran through a centrifuge in order to isolate the BMAC containing MSCs. The BMAC will be injected into the ACL allograft prior to implanting into the patient.
  • Placebo Comparator: Control Sham Incision
    Patients will receive a sham incision on the anterior superior iliac spine where the bone marrow aspirate is obtained in the the experimental group. This ensures proper blinding. The patient will receive the normal standard of care.

Primary Outcome Measure

Signal to Noise Quotient [ Time Frame: 9 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60521-

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Rush University Medical Center· Chicago, IL

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