NCT02230514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

4.3 years

First QC Date

July 17, 2014

Last Update Submit

April 7, 2021

Conditions

Atrophic Nonunion of Fracture

Keywords

Nonunion fractureLong bonesPseudoarthrosisCell therapyTissue engineeringMesenchymal stromal cells

Outcome Measures

Primary Outcomes (1)

  • Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures

    Hounsfield units quantification by tomography in both treatment arms

    12 month

Secondary Outcomes (3)

  • Safety assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures

    12 month

  • Efficacy assessment of XCEL-MT-OSTEO-ALPHA in non-union fractures by imaging procedures

    6 month

  • Efficacy assessment by quality of life test

    12 month

Study Arms (2)

XCEL-MT-OSTEO-ALPHA and surgery

EXPERIMENTAL

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

Drug: XCEL-MT-OSTEO-ALPHAProcedure: Surgery

Autologous iliac crest and surgery

OTHER

Standard treatment

Other: autologous iliac crestProcedure: Surgery

Interventions

XCEL-MT-OSTEO-ALPHADRUG

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

XCEL-MT-OSTEO-ALPHA and surgery
autologous iliac crestOTHER

Autologous iliac crest in association with surgery

Autologous iliac crest and surgery
SurgeryPROCEDURE

Standard surgery for non-union fractures

Autologous iliac crest and surgeryXCEL-MT-OSTEO-ALPHA and surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital ASEPEYO Sant Cugat

Sant Cugat del Vallès, Barcelona, 08174, Spain

Location

Related Links

MeSH Terms

Conditions

Fractures, UnunitedPseudarthrosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Fernando Granell, MD, PhD

    Hospital ASEPEYO Sant Cugat

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Radiologist will assess images in a blinded manner
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

September 3, 2014

Study Start

November 20, 2014

Primary Completion

March 5, 2019

Study Completion

December 20, 2019

Last Updated

April 12, 2021

Record last verified: 2021-04

Locations

ES(1)