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

Long Bone Nonunion Clinical Trial

Official title:

Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581892
• Other study ID #: HUCA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 9, 2012
• Last updated: August 24, 2015
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: August 2015
• Source: Hospital Universitario Central de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Long Bone Nonunion

Intervention

Procedure:
• Osteosynthesis
To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Central de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of adverse effects during timeframe as infections or complications related with the intervention	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.	Six months	Yes
Secondary	Improvement and union of the bone	The improvement of the bone nonunion will be assessed by X-ray and NMR	One year	No