Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

NCT02582489 | Active Not Recruiting FDA Device

• 1 other identifier: 15090903
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.

Conditions

Osteoarthritis Post-meniscectomy

Keywords

Mesenchymal stem cells; Bone marrow aspirate concentrate

Outcome Measures

Primary Outcomes (1)

• International Knee Documentation Committee (IKDC) Score

  The primary outcome measure will be the IKDC score at one year follow-up

  One Year

Secondary Outcomes (7)

• Patient reported outcomes throughout follow-up period

  7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Synovial fluid analysis

  2 weeks, 6 weeks

• Radiographic analysis

  1 year, 2 years

• Patient reported outcomes throughout follow-up period (VAS)

  7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Patient reported outcomes throughout follow-up period (IKDC)

  7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

Study Arms (2)

Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)

EXPERIMENTAL

Subjects will undergo the scheduled meniscectomy procedure. Following the procedure the investigator will make a small incision and create the marrow access channel in the proximal tibia. The experimental group will then have bone marrow harvested and BMAC will be prepared using a BMAC harvesting system. The automated centrifuge system rapidly concentrates cellular contents and growth factors in bone marrow aspirate using flow cytometry. The BMAC will be injected intra-articularly.

Biological: Bone Marrow Aspirate Concentrate; Procedure: Standard Meniscectomy

Meniscectomy with Placebo

PLACEBO COMPARATOR

Subjects will undergo the same meniscectomy procedure and will also have an incision and marrow access channel made in the proximal tibia, however no bone marrow will be harvested. The control group will have a placebo injection of saline into the affected knee.

Procedure: Standard Meniscectomy

Interventions

Standard Meniscectomy PROCEDURE

All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.

Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC); Meniscectomy with Placebo

Bone Marrow Aspirate Concentrate BIOLOGICAL

Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.

Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is greater than 18 years old
• Written informed consent is obtained
• Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy
• Meniscal pathology is confirmed through MRI and arthroscopically
• Subject agrees to all follow-up evaluations
• Osteoarthritis Kellen-Lawrence grade 1-3 on flexion PA and extension AP views

You may not qualify if:

• Any subject lacking decisional capability
• Unwillingness to participate in the necessary follow-up
• Subject is pregnant or may become pregnant
• History of diabetes mellitus
• History of rheumatoid arthritis or other autoimmune disorder
• History of solid organ or hematologic transplantation
• Diagnosis of a non-basal cell malignancy within the preceding 5 years
• Infection requiring antibiotic treatment within the preceding 3 months
• Osteoarthritis Kellen-Lawrence grade 4 on flexion posterior-anterior (PA) or extension anteroposterior (AP) views
• Prior surgery on the index meniscus
• Concomitant surgery such as ligament surgery or cartilage repair or restoration
• Infection
• Prior cortisone/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (7)

• Fortier LA, Potter HG, Rickey EJ, Schnabel LV, Foo LF, Chong LR, Stokol T, Cheetham J, Nixon AJ. Concentrated bone marrow aspirate improves full-thickness cartilage repair compared with microfracture in the equine model. J Bone Joint Surg Am. 2010 Aug 18;92(10):1927-37. doi: 10.2106/JBJS.I.01284.

  PMID: 20720135 BACKGROUND

• Gobbi A, Karnatzikos G, Scotti C, Mahajan V, Mazzucco L, Grigolo B. One-Step Cartilage Repair with Bone Marrow Aspirate Concentrated Cells and Collagen Matrix in Full-Thickness Knee Cartilage Lesions: Results at 2-Year Follow-up. Cartilage. 2011 Jul;2(3):286-99. doi: 10.1177/1947603510392023.

  PMID: 26069587 BACKGROUND

• Enea D, Cecconi S, Calcagno S, Busilacchi A, Manzotti S, Gigante A. One-step cartilage repair in the knee: collagen-covered microfracture and autologous bone marrow concentrate. A pilot study. Knee. 2015 Jan;22(1):30-5. doi: 10.1016/j.knee.2014.10.003. Epub 2014 Nov 20.

  PMID: 25480381 BACKGROUND

• Kim JD, Lee GW, Jung GH, Kim CK, Kim T, Park JH, Cha SS, You YB. Clinical outcome of autologous bone marrow aspirates concentrate (BMAC) injection in degenerative arthritis of the knee. Eur J Orthop Surg Traumatol. 2014 Dec;24(8):1505-11. doi: 10.1007/s00590-013-1393-9. Epub 2014 Jan 8.

  PMID: 24398701 BACKGROUND

• Centeno C, Pitts J, Al-Sayegh H, Freeman M. Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int. 2014;2014:370621. doi: 10.1155/2014/370621. Epub 2014 Sep 7.

  PMID: 25276781 BACKGROUND

• Vangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058.

  PMID: 24430407 BACKGROUND

• Yanke AB, Yazdi AA, Weissman AC, Wagner KR, Meeker ZD, Condron NB, Darwish RY, Drager J, Danilkowicz RM, Forsythe B, Verma NN, Cole BJ. A Prospective, Randomized, Double-Blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate During Arthroscopic Meniscectomy in Patients With Early Knee Osteoarthritis. Am J Sports Med. 2024 Oct;52(12):2963-2971. doi: 10.1177/03635465241275647. Epub 2024 Sep 15.

  PMID: 39279266 DERIVED

Study Officials

• Brian J Cole, MD, MBA

  Midwest Orthopaedics at Rush

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: December 22, 2017
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)