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

NCT01581892 | Completed Phase 1

• 1 other identifier: HUCA
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long Bone Nonunion

Keywords

bone nonunion; bone marrow; mononuclear; fracture

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Improvement and union of the bone

  One year

Study Arms (1)

Bone marrow stem cells

EXPERIMENTAL

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

Interventions

Osteosynthesis PROCEDURE

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

Also known as: bone nonunion, bone marrow, mononuclear, fracture

Bone marrow stem cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed long bone nonunion
• age from 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Central de Asturias: lead

Study Sites (1)

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Related Publications (1)

• Fernandez-Bances I, Perez-Basterrechea M, Perez-Lopez S, Nunez 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.

  PMID: 23415918 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Fracture Fixation, Internal; leukocyte procoagulant activity

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jesus Otero, MD

  Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: April 20, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: January 1, 2013
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

ES (1)