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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02297256
Other study ID # 12-02411
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 2012
Est. completion date December 1, 2025

Study information

Verified date September 2023
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a single-center, prospective randomized clinical study intended to compare and evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate (BMAC) and allograft to iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.


Description:

Subjects who are candidates for posterior lumbar or lumbosacral spinal fusion without anterior interbody support will be screened for inclusion in the study. Participants will be enrolled and randomized to either the BMAC + allograft or ICBG group. An enrollment ratio of two BMAC + allograft to one ICBG subject (2:1) for up to a total of 40 subjects will be enrolled in the study which also accounts for failed screening subjects. The study will determine and compare differences in fusion rate and health related quality of life parameters at 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 17
Est. completion date December 1, 2025
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Must be 18 years old or older - Scheduled for elective posterior spinal fusion of the thoracolumbar spine or lumbar spine with or without anterior interbody support - Failed at least 6 weeks of conservative care - ODI v2.1 score > 30% - No contraindication to BMAC (as per manufacturer) - Signed consent form Exclusion Criteria: - Spondylolisthesis grade = 3 - Pagets disease, osteomalacia, or any metabolic bone disease - Use of medications that interfere with bone healing (chronic steroids) - Patient unlikely to comply with post-op schedule with physician - Recent history of chemical dependency - Participation in other investigational device trial(s) within past 30 days - Active malignancy - Pregnancy or planning to become pregnant - Direct involvement in execution of this protocol

Study Design


Intervention

Procedure:
BMAC & Allograft
Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.
Iliac Crest Bone Graft
Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.

Locations

Country Name City State
United States Center for Musculoskeletal Care (CMC) New York New York
United States NYU Hospital for Joint Diseases New York New York
United States NY Spine Institute Westbury New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, Kearne M, Magner M, Isner JM. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999 Aug 6;85(3):221-8. doi: 10.1161/01.res.85.3.221. — View Citation

Gan Y, Dai K, Zhang P, Tang T, Zhu Z, Lu J. The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusion. Biomaterials. 2008 Oct;29(29):3973-82. doi: 10.1016/j.biomaterials.2008.06.026. Epub 2008 Jul 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CT scan to assess fusion status Pre-operative, Post Operative 1 Year
Primary Oswestry Disability Index (ODI) Pre-operative, Post Operative 1 Year
Primary Short Form Health Survey (SF-12) Pre-op, Post Operative 1 Year
Primary Numeric Pain Rating Scale Pre-op, Post Operative 1 Year
Primary Length of Stay Post Operative 1 Year
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