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Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion

This study is currently recruiting participants.
Verified April 2012 by Hospital Universitario Central de Asturias
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier:
NCT01581892
First received: April 9, 2012
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.


Condition Intervention Phase
Long Bone Nonunion
 Procedure: Osteosynthesis
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Hospital Universitario Central de Asturias:

Primary Outcome Measures:
  • Absence of adverse effects during timeframe as infections or complications related with the intervention [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline and used in order to infuse into the area surgically treated. The surgical intervention means the introduction of a sheet with nails according with the usually employed technique.


Secondary Outcome Measures:
  • Improvement and union of the bone [ Time Frame: One year ] [ Designated as safety issue: No ]
    The improvement of the bone nonunion will be assessed by X-ray and NMR


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bone marrow stem cells
Bone marrow is obtained by posterosuperior iliac crest aspiration under topical anesthesia. Mononuclear cells were isolated by Ficoll density gradient and will be resuspended in heparinized isotonic saline for mixing with osteogenic matrix.
 Procedure: Osteosynthesis
To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture
Other Names:
  • bone nonunion
  • bone marrow
  • mononuclear
  • fracture

Detailed Description:

In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed long bone nonunion
  • age from 18 years old

Exclusion Criteria:

  • active infection
  • cancer patients
  • concomitant serious illness
  • pregnant women
  • evidences of mental illness
  • previous alcohol or drug dependences
  • previous malignant disease during last 5 years, except for basal carcinoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581892

Contacts
Contact: Jesús Otero, MD +34985108778 jesus.otero@sespa.princast.es

Locations
Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33006
Contact: Jesus Otero, MD     +34985108778     jesus.otero@sespa.princast.es    
Contact: Jesus Otero, MD     +34985108778     jesus.otero@sespa.princast    
Principal Investigator: Jesus Otero, MD            
Sponsors and Collaborators
Hospital Universitario Central de Asturias
Investigators
Principal Investigator: Jesus Otero, MD Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa
  More Information

No publications provided

Responsible Party: Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier: NCT01581892     History of Changes
Other Study ID Numbers: HUCA
Study First Received: April 9, 2012
Last Updated: April 19, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitario Central de Asturias:
bone nonunion
bone marrow
mononuclear
fracture

ClinicalTrials.gov processed this record on May 16, 2013