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

April 7, 2021 updated by: Banc de Sang i Teixits

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat, Barcelona, Spain, 08174
        • Hospital Asepeyo Sant Cugat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Procedure: Surgery
Standard surgery for non-union fractures
Other: autologous iliac crest
Autologous iliac crest in association with surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
6 month
Efficacy assessment by quality of life test
Time Frame: 12 month
Quality of life will be measured by EUROQOL-5D test
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banc de Sang i Teixits

Collaborators

Hospital ASEPEYO Sant Cugat

Investigators

  • Principal Investigator: Fernando Granell, MD, PhD, Hospital Asepeyo Sant Cugat

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2014

Primary Completion (Actual)

March 5, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XCEL-PSART-01
  • 2013-005025-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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