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

NCT04650568 | Enrolling By Invitation FDA Device

• 1 other identifier: 17082504
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anterior Cruciate Ligament; ACL; Stem Cell; Mesenchymal stem cells; biologic; augmentation

Outcome Measures

Primary Outcomes (1)

• Signal to Noise Quotient

  Signal intensity of the ACL graft on T2 weighted MRI imaging compared to a reference structures' signal intensity

  9 months

Secondary Outcomes (4)

• Side to side difference in anterior tibial translation

  6 weeks, 3 months, 6 months, 9 months, 1 year

• Patient reported outcomes- Tegner Score

  3 months, 6 months, 9 months, 12 months, 24 months

• Patient reported outcomes- Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)

  3 months, 6 months, 9 months, 12 months, 24 months

• Patient reported outcomes- International Knee Documentation Committee (IKDC) Score

  3 months, 6 months, 9 months, 12 months, 24 months

Study Arms (2)

Mesenchymal Stem Cell Recipient

EXPERIMENTAL

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.

Device: Autologous Bone Marrow Derived Mesenchymal Stem Cells

Control Sham Incision

PLACEBO COMPARATOR

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.

Other: Sham incision

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.

Also known as: Sham Incision

Mesenchymal Stem Cell Recipient

Sham incision OTHER

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

Control Sham Incision

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• English-speaking patients
• years of age with acute ACL injury (\<6 months from time of injury to reconstruction) and undergoing reconstruction with patellar tendon allograft
• Written informed consent is obtained

You may not qualify if:

• Revision Surgery
• Prior history of knee surgery
• Concomitant ligamentous injury
• Inability to obtain an MRI
• Inability to participate in follow-up for the study
• Any patient lacking decisional capability
• Diagnosed musculoskeletal cancer or any diagnosed cancer, other than
• musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
• Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection or use of systemic steroids)
• Known history of HIV, or has active Hepatitis B or active Hepatitis C
• Alcohol and drug (medication) abuse
• Pregnant or breast feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
• Patients that have received PRP, other platelet-based product, or investigational treatment in another cell/biologic study for the target knee in the 12 months prior to the injection procedure
• Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
• Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60521, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient remains blinded throughout trial. Imaging evaluator will be blinded to which study arm the patient belongs to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 2, 2020
• Study Start: November 3, 2017
• Primary Completion: May 3, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)