NCT01603836

Brief Summary

The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing. Allograft by itself is not an effective material as a posterior onlay graft for the PLF in adult surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

1.1 years

First QC Date

May 15, 2012

Last Update Submit

May 20, 2012

Conditions

Spondyloarthrosis, Spondylosis

Keywords

Lumbar spinePosterolateral fusionAllograftBone marrow concentrateMesenchymal stem cellsFusion rate

Outcome Measures

Primary Outcomes (2)

  • The improvement of the fusion of the posterolateral fusion measured on X-rays

    Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

    12 months after the surgery

  • The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans.

    Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

    24months after the surgery

Study Arms (1)

bone marrow concentrate

EXPERIMENTAL

In forty cases, the posterolateral fusion was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

Biological: bone allogaft with bone marrow concentrate

Interventions

bone allogaft with bone marrow concentrateBIOLOGICAL

In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

bone marrow concentrate

Eligibility Criteria

Age45 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • degenerative disc disease or degenerative spondylolisthesis

You may not qualify if:

  • vertebral fractures,
  • infections or spinal neoplasms,
  • non-rigid instrumentations,
  • medication affecting bone mineralization (e.g., corticosteroids),
  • body mass index higher than 35,
  • systemic diseases,
  • blood disease and/or immunosuppressant treatment and/or dicoumarol therapy;
  • immunosuppressant and/or neoplastic and/or infectious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SpondylarthritisSpondylosis

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 23, 2012

Study Start

February 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2012

Last Updated

May 23, 2012

Record last verified: 2012-05