Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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|
- 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.
- 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
|Study Start Date:||December 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581892
|Hospital Universitario Central de Asturias|
|Oviedo, Asturias, Spain, 33006|
|Principal Investigator:||Jesus Otero, MD||Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa|