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

Sponsor

Banc de Sang i Teixits (Other)

Overall Status

Completed

CT.gov ID

NCT02230514

Collaborator

Hospital ASEPEYO Sant Cugat (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrophic Nonunion of Fracture	Drug: XCEL-MT-OSTEO-ALPHA Other: autologous iliac crest Procedure: Surgery	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Radiologist will assess images in a blinded manner

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 20, 2014

Actual Primary Completion Date :

Mar 5, 2019

Actual Study Completion Date :

Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XCEL-MT-OSTEO-ALPHA and surgery "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue	Drug: XCEL-MT-OSTEO-ALPHA "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery Procedure: Surgery Standard surgery for non-union fractures
Other: Autologous iliac crest and surgery Standard treatment	Other: autologous iliac crest Autologous iliac crest in association with surgery Procedure: Surgery Standard surgery for non-union fractures

Arm

Intervention/Treatment

Experimental: XCEL-MT-OSTEO-ALPHA and surgery

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

Drug: XCEL-MT-OSTEO-ALPHA

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

Procedure: Surgery

Standard surgery for non-union fractures

Other: Autologous iliac crest and surgery

Standard treatment

Other: autologous iliac crest

Autologous iliac crest in association with surgery

Procedure: Surgery

Standard surgery for non-union fractures

Outcome Measures

Primary Outcome Measures

Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures [12 month]
Hounsfield units quantification by tomography in both treatment arms

Secondary Outcome Measures

Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures [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 [6 month]
Characteristics of the callus by tomography and Characteristics of the callus by standard x-ray in both treatment arms
Efficacy assessment by quality of life test [12 month]
Quality of life will be measured by EUROQOL-5D test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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