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

This study has been completed.
Information provided by (Responsible Party):
Hospital Universitario Central de Asturias Identifier:
First received: April 9, 2012
Last updated: August 24, 2015
Last verified: August 2015
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: 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01581892

Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Sponsors and Collaborators
Hospital Universitario Central de Asturias
Principal Investigator: Jesus Otero, MD Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa
  More Information

Responsible Party: Hospital Universitario Central de Asturias Identifier: NCT01581892     History of Changes
Other Study ID Numbers: HUCA
Study First Received: April 9, 2012
Last Updated: August 24, 2015

Keywords provided by Hospital Universitario Central de Asturias:
bone nonunion
bone marrow
fracture processed this record on April 28, 2017