Clinical Trial Based on the Use of Mononuclear Cells From Autologous Bone Marrow in Patients With Pseudoarthrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Carlos III Health Institute
Hospital Universitario Virgen de la Arrixaca
Information provided by (Responsible Party):
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier:
NCT01813188
First received: June 22, 2011
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone graft.


Condition Intervention Phase
Pseudoarthrosis
Procedure: ABM seeded onto a porous TCP and DBM
Procedure: autologous bone graft
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Tissue Engineering Based on the Use of Mononuclear Cells From Autologous Bone Marrow Seeded on Porous Tricalcium Phosphate Biomaterial in Patients With Pseudoarthrosis

Resource links provided by NLM:


Further study details as provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:

Primary Outcome Measures:
  • Time needed to repair the focus of necrosis measured by pain radiography [ Time Frame: Baseline and every 14 days up to 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain scale [ Time Frame: Baseline and every 14 days up to 180 days ] [ Designated as safety issue: No ]
  • Technical success [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Understood as having been able to perform the implant of calcium phosphate matrix loaded with more than 100 million mononuclear cells

  • Morbidity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Infection of extraction points Pathological fracture of the extraction area Muscle hernia Stress fracture Infection of focus repaired Rupture of the focus fixture repaired Appearance of secondary malignancies

  • Absence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • physical exploratory [ Time Frame: Baseline and every 14 days up to 180 days ] [ Designated as safety issue: No ]
  • Analgesia Scale [ Time Frame: Baseline and every 14 days up to 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABM seeded onto a porous TCP and DBM
ABM seeded onto a porous TCP and DBM
Procedure: ABM seeded onto a porous TCP and DBM

cells collection under sedation . 114 mL are obtained and processed through a ficoll gradient.

Autologous bone marrow (ABM) cells seeded onto a porous tricalcium phosphate ceramic (TCP) and demineralized bone matrix (DBM)

Active Comparator: autologous bone graft
autologous bone graft
Procedure: autologous bone graft
autologous bone graft

Detailed Description:

An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at risk of developing a delay in the process of consolidation or a complete failure of it (pseudoarthrosis) depending on location , severity of trauma on bone, soft tissue and vascular structures Some of these cases are refractory to all treatment methods available today, requiring numerous interventions with the potential risk for recurrent infections that they carry. For this reason, its treatment remains a challenge for the orthopedic surgeon.

Recent advances in knowledge of cellular and molecular biology related to the mechanism of bone repair and biomaterials science have been joined in a new discipline called tissue engineering, its implementation in clinical practice is being done so progressive.

Cell therapy based on the use of adult stem cells (MSCs) derived from autologous bone marrow, introduces new applications for the repair of fractures including pseudoarthrosis and avascular bone necrosis.

Its mechanism of action does not focus only on their local action, but also in the release of signaling molecules with autocrine and paracrine action through recruitment and activation of endogenous MSCs to osteoblastic differentiation and bone tissue regeneration.

On the other hand, the seeding of MSCs on biomaterials (natural or synthetic) is more effective, to facilitate adherence, proliferation and extracellular matrix production in the area where implanted.

Today, the investigators can say that there are experimental and clinical evidence supporting the effectiveness of the method.

The investigators have designed a phase II clinical trial to check the feasibility of this approach.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pseudarthrosis of tibia established any cause with at least 9 months.
  • The pseudarthrosis is not to show signs of healing in the last 3 months.
  • The pseudarthrosis subsidiary should not be solely osteosynthesis treatment.
  • Age between 18 and 75 years.
  • Serology Human Immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) negative.
  • Negative pregnancy test in women of childbearing age.
  • Patient sufficient guarantees of adherence to protocol.
  • Signature written informed consent before a witness

Exclusion Criteria:

  • Systemic infection.
  • Septic pseudoarthrosis.
  • Insufficient skin coverage at the site of nonunion.
  • Vascular insufficiency in the affected limb.
  • Pathological fracture.
  • Concomitant psychiatric or neurological disease.
  • Concurrent or prior malignancy treated with chemotherapy over a period of less than 1 year.
  • Concomitant severe disease not well controlled.
  • Inclusion in other clinical trials.
  • Inability to understand the informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01813188

Locations
Spain
Hospital UniversitarioVirgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Sponsors and Collaborators
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Carlos III Health Institute
Hospital Universitario Virgen de la Arrixaca
Investigators
Principal Investigator: Luis Meseguer Olmo, MD,PhD Hospital Universitario Virgen de la Arrixaca
  More Information

No publications provided

Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
ClinicalTrials.gov Identifier: NCT01813188     History of Changes
Other Study ID Numbers: TCBO-PS
Study First Received: June 22, 2011
Last Updated: March 17, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia:
Fractures
Bone
Stem Cells

Additional relevant MeSH terms:
Pseudarthrosis
Fractures, Ununited
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 20, 2014