Recruiting

Concentrated Bone Marrow Aspirate

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT06311513

Conditions

Anterior Cruciate Ligament Injuries

Post-Traumatic Osteoarthritis of Knee

Bone Marrow Aspirate Concentrate

ACL Injury

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Concentrated Bone Marrow Aspirate Injection

Sham Incision

Revision Anterior Cruciate Ligament Reconstruction

Study Details

Brief summary:

The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.

Conditions

Anterior Cruciate Ligament Injuries

Post-Traumatic Osteoarthritis of Knee

Bone Marrow Aspirate Concentrate

ACL Injury

Study ID

NCT06311513

Start date

Jan 22, 2024

Status verified date

Nov, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and Females
  • Age 18 to 55
  • Previous unilateral ACLR (Anterior Cruciate Ligament Reconstruction) within the last 5 years, and identified as having experienced failure of the primary ACLR
  • Scheduled to have a revision ACLR surgery, with any graft type (including patellar tendon, hamstring, quad or allograft)
  • Able to complete all study procedures and participate in a standardized physical therapy program

Exclusion Criteria:

  • History of inflammatory arthritis or joint sepsis
  • Prior or concurrent total or sub-total meniscectomy
  • Prior or present avascular necrosis of the index knee
  • Oral or intra-articular corticosteroid injection within 3 months
  • Hyaluronic acid or PRP (Platelet-Rich Plasma) injection within 6 months
  • Use of duloxetine, doxycycline, indomethacin, glucosamine and/or chondroitin (ongoing or within 2 months)
  • Any clinical or laboratory abnormality greater than grade 3 CTCAE, which in the view of the investigator, will compromise the participant's safety.
  • Planned arthroplasty in the index knee

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Investigational Arm

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).

sham comparator: Control Arm

Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.

Interventions

Concentrated Bone Marrow Aspirate Injection

Intraoperatively, bone marrow will be harvested from the iliac crest with a commercial kit, it will then be prepared via centrifugation and an injection of the resulting concentrated product (cBMA) will be administered in the operative knee. cBMA is an autologous biologic product.

Sham Incision

A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.

Revision Anterior Cruciate Ligament Reconstruction

This is the standard-of-care surgical procedure.

Primary outcome measure

  • Change from baseline in patient reported knee pain [ Time Frame: Baseline, 6 weeks, 6 months, 12 months and 24 months post-operative ]

Central Contacts and Locations

Central contacts

Daniel de la Huerta, MD

917-260-3159delahuertamezad@hss.edu

Locations

Emory Orthopaedics & Spine Center

Recruiting

Atlanta, Georgia, United States, 30097

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Daniel de la Huerta, MD

212-606-1000delahuertamezad@hss.edu

Principal Investigator:

Miguel Otero, Ph.D.

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Keywords

  • Regenerative Medicine
  • Orthobiologics
  • Concentrated Bone Marrow Aspirate
  • Revision ACLR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2025-11-20.