NCT01552707

Brief Summary

The present prospective, randomized study, compares the spinal fusion obtained after instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from his/her own bone marrow which will be fixed in human bone tissue form a donor), with the current procedure that consists in instrumented spinal fusion and the use of each patient's bone obtained from his/her iliac crest. The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its associated morbidity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

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

March 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 19, 2012

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2019

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

5.8 years

First QC Date

March 8, 2012

Last Update Submit

January 15, 2020

Conditions

Lumbar Spondylolisthesis Involving L4-L5, and/orDegenerative Discopathy Involving L4-L5

Keywords

SpondylolisthesisDegenerative discopathyMesenchymal Stem CellsBone marrowTissue engineeringSpinal fusion

Outcome Measures

Primary Outcomes (2)

  • safety of XCEL-MT-OSTEO-ALPHA (tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)

    Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months

    12 months

  • Feasibility of XCEL-MT-OSTEO-ALPHA (composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion)

    Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable.

    12 months

Secondary Outcomes (5)

  • Efficacy spinal fusion by imaging procedures (X-Ray).

    3, 6 and 12 months

  • Efficacy spinal fusion by imaging procedures (computerized helicoidal tomography)

    6 and 12 months

  • Clinical outcomes (VAS)

    7 days and at 3, 6 and 12 months

  • Clinical outcomes (SF-36)

    3, 6 and 12 months

  • Clinical outcome (Oswestry Disability Index)

    3, 6 and 12 months

Study Arms (2)

XCEL-MT-OSTEO-ALPHA

EXPERIMENTAL

"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue for spinal fusion

Biological: XCEL-MT-OSTEO-ALPHA

Standard treatment

SHAM COMPARATOR

Instrumented spinal fusion together with patient's bone iliac crest.

Procedure: Standard treatment

Interventions

XCEL-MT-OSTEO-ALPHABIOLOGICAL

Isolation and "ex-vivo" expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, División de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion.

XCEL-MT-OSTEO-ALPHA
Standard treatmentPROCEDURE

Instrumented spinal fusion together with patient's bone iliac crest

Standard treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • L4-L5 degenerative spondylolisthesis grade I-II Meyerding isolated or associated to more than one level, and/or L4-L5 degenerative discopathy isolated or associated to more than one level.
  • to 85 years of age (male and female)
  • Informed Consent Form signed
  • The patient is able to understand the nature of the study

You may not qualify if:

  • Previous spine surgery
  • L4 isthmic spondylolisthesis
  • Smoker (more than 10 cigarettes a day)
  • Systemic or local infection
  • Patients treated with steroids (oral or systemic) within 3 months of entering the study, or treated with biphosphonates for more than 10 years
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis.
  • Pregnant woman or intended to become pregnant, or breath feeding
  • Neoplasia within the previous 5 years, or without remission
  • Immunosuppressive states (except diabetes mellitus. Treatment with therapies is allowed)
  • Significant abnormal laboratory tests that contraindicates the surgery.
  • Participation in another clinical trial or treated with an investigational medicinal product the previous 3 months
  • 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
  • The patient is legally dependent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Parc de Salut Mar

Barcelona, 08003, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Institut Universitari Dexeus (ICATME)

Barcelona, 08028, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (1)

  • Vives J, Oliver-Vila I, Pla A. Quality compliance in the shift from cell transplantation to cell therapy in non-pharma environments. Cytotherapy. 2015 Aug;17(8):1009-14. doi: 10.1016/j.jcyt.2015.02.002. Epub 2015 Mar 10.

    PMID: 25769789DERIVED

Related Links

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Joan Bagó, MD, PhD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 13, 2012

Study Start

July 19, 2012

Primary Completion

May 3, 2018

Study Completion

October 21, 2019

Last Updated

January 21, 2020

Record last verified: 2020-01

Locations

ES(5)