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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581892
First Posted: April 20, 2012
Last Update Posted: August 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital Universitario Central de Asturias
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study

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 ]
    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 ]
    The improvement of the bone nonunion will be assessed by X-ray and NMR


Enrollment: 7
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581892


Locations
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
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

Publications:
Responsible Party: Hospital Universitario Central de Asturias
ClinicalTrials.gov Identifier: NCT01581892     History of Changes
Other Study ID Numbers: HUCA
First Submitted: April 9, 2012
First Posted: April 20, 2012
Last Update Posted: August 25, 2015
Last Verified: August 2015

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