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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Hospital Universitario Central de Asturias.
Recruitment status was  Recruiting
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

April 9, 2012
April 19, 2012
December 2011
December 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01581892 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2013
December 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
Both
18 Years and older
No
Contact: Jesús Otero, MD +34985108778 jesus.otero@sespa.princast.es
Spain
 
NCT01581892
HUCA
No
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
April 2012

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