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

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. Identifier: NCT01581892
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):
Hospital Universitario Central de Asturias

April 9, 2012
April 20, 2012
August 25, 2015
December 2011
September 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01581892 on Archive Site
Improvement and union of the bone [ Time Frame: One year ]
The improvement of the bone nonunion will be assessed by X-ray and NMR
Same as current
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Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion
Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study
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.
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.
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Long Bone Nonunion
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
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.
Intervention: Procedure: Osteosynthesis
Fernandez-Bances I, Perez-Basterrechea M, Perez-Lopez S, Nuñez Batalla D, Fernandez Rodriguez MA, Alvarez-Viejo M, Ferrero-Gutierrez A, Menendez-Menendez Y, Garcia-Gala JM, Escudero D, Paz Aparicio J, Carnero Lopez S, Lopez Fernandez P, Gonzalez Suarez D, Otero Hernandez J. Repair of long-bone pseudoarthrosis with autologous bone marrow mononuclear cells combined with allogenic bone graft. Cytotherapy. 2013 May;15(5):571-7. doi: 10.1016/j.jcyt.2013.01.004. Epub 2013 Feb 14.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2013
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Hospital Universitario Central de Asturias
Hospital Universitario Central de Asturias
Not Provided
Principal Investigator: Jesus Otero, MD Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa
Hospital Universitario Central de Asturias
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP