Clinical Trial: Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase IIa, Single Center, Prospective, Randomized, Parallel, Two-arms, Single-dose, Open-label With Blinded Assessor Pilot Clinical Trial to Assess ex Vivo Expanded Adult Autologous Mesenchymal Stro

Brief Summary:

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest.

XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia).

The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.


Detailed Summary: A phase IIa, single center, prospective, randomized, parallel, two-arms, single-dose, open-label with blinded assessor pilot clinical trial to assess ex vivo expanded adult autologous mesenchymal stromal cells fixed in allogeneic bone tissue (XCEL-MT-OSTEO-ALPHA) in non hypertrophic pseudoarthrosis of long bones.
Sponsor: Banc de Sang i Teixits

Current Primary Outcome: Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures [ Time Frame: 12 month ]

Hounsfield units quantification by tomography in both treatment arms


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures [ Time Frame: 12 month ]
    Safety will be assessed by collecting adverse events throughout the experimental phase which includes a follow-up of 12 month.
  • Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures [ Time Frame: 6 month ]
    Characteristics of the callus by tomography and Characteristics of the callus by standard x-ray in both treatment arms
  • Quality of life [ Time Frame: 12 month ]
    Quality of life will be measured by EUROQOL-5D test


Original Secondary Outcome: Same as current

Information By: Banc de Sang i Teixits

Dates:
Date Received: July 17, 2014
Date Started: December 2014
Date Completion: September 2018
Last Updated: December 14, 2016
Last Verified: December 2016