Trial | NCT02230514  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    19
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.
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.
Study Started
Nov 20
2014
Primary Completion
Mar 05
2019
Study Completion
Dec 20
2019
Last Update
Apr 12
2021

Drug XCEL-MT-OSTEO-ALPHA

"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery

Other autologous iliac crest

Autologous iliac crest in association with surgery

Procedure Surgery

Standard surgery for non-union fractures

XCEL-MT-OSTEO-ALPHA and surgery Experimental

"ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue

Autologous iliac crest and surgery Other

Standard treatment

Criteria 

Inclusion Criteria:

18 to 85 years of age (male and female)
Atrophic or hypotrophic metaphyseal-diaphyseal pseudarthrosis of long bones, confirmed radiographically.
Signed Informed Consent Form
The patient is able to understand the nature of the study

Exclusion Criteria:

Suspicious of pseudarthrosis focus infection diagnosed by clinical inspection and blood analysis.
Positive serology for HIV (Anti-HIV I/II-Ac), Hepatitis B (HBsAg, HBcAc), Hepatitis C (Anti-HCV-Ac) or Syphilis Lúes (TP-Ac).
Significant abnormal laboratory tests that contraindicates patient's participation in the study.
Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
Smoker of more than 15 cigarettes a day
Congenital disorders of bones (hypophosphatemia), bone metabolic disorders associated to primary or secondary hypoparathyroidism.
Badly managed diabetes mellitus.
Patients diagnosed with peripheral arterial disorders
Previous therapeutic radiation (5 previous years) of the affected bone.
Neoplasia within the previous 5 years, or without remission
The patient is legally dependent
Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
The patient does not accept to be followed-up for a period that could exceed the clinical trial length
No Results Posted