Clinical trial NCT02230514: Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones
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 Stromal Cells Fixed in Allogeneic Bone Tissue (XCEL-MT-OSTEO-ALPHA) in Non Hypertrophic Pseudoarthrosis of Long Bones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atrophic Nonunion of Fracture
Keywords: Nonunion fracture
Long bones
Pseudoarthrosis
Cell therapy
Tissue engineering
Mesenchymal stromal cells
Lead sponsor: Banc de Sang i Teixits
Sponsor class: OTHER
Collaborators: name: Hospital ASEPEYO Sant Cugat
First posted: 2014-09-03
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility 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

Primary outcomes:
measure: Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
timeFrame: 12 month
Secondary outcomes:
measure: Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures
timeFrame: 12 month
measure: Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures
timeFrame: 6 month
measure: Efficacy assessment by quality of life test
timeFrame: 12 month
Other outcomes:
Locations:
city: Sant Cugat
country: Spain
facility: Hospital ASEPEYO Sant Cugat
state: Barcelona
Study officials:
affiliation: Hospital ASEPEYO Sant Cugat
name: Fernando Granell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: