NCT01513694

Brief Summary

The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2010

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

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2017

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

7.3 years

First QC Date

January 16, 2012

Last Update Submit

June 1, 2017

Conditions

Intervertebral Disc Disease

Keywords

Mesenchymal Stem CellsStem CellsIntervertebral disc disease

Study Arms (1)

MSC seeded onto a phosphate ceramic

EXPERIMENTAL

Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.

Procedure: Instrumented posterolateral arthrodesis

Interventions

Instrumented posterolateral arthrodesisPROCEDURE

Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight. Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.

MSC seeded onto a phosphate ceramic

Eligibility Criteria

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

You may qualify if:

  • Clinical
  • Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
  • Discopathy refractory to conservative treatment (drugs, physical therapy.)
  • Evolution greater than or equal to 6 months. Radiological
  • Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
  • NMR: grades IV and V of Pfirman.

You may not qualify if:

  • Rejection of surgical treatment.
  • Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
  • Immunosuppressive treatment.
  • Congenital or acquired anatomical abnormality that prevents the surgical procedure.
  • Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
  • High surgical risk (ASA\> IV), or contraindication to anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trauma Service. Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Related Publications (2)

  • Gomez-Ruiz V, Blanco JF, Villaron EM, Fidalgo H, Lopez-Parra M, Sanchez-Guijo F. Autologous mesenchymal stem cell transplantation for spinal fusion: 10 years follow-up of a phase I/II clinical trial. Stem Cell Res Ther. 2023 Apr 11;14(1):78. doi: 10.1186/s13287-023-03298-4.

    PMID: 37038216DERIVED

  • Blanco JF, Villaron EM, Pescador D, da Casa C, Gomez V, Redondo AM, Lopez-Villar O, Lopez-Parra M, Muntion S, Sanchez-Guijo F. Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2019 Feb 22;10(1):63. doi: 10.1186/s13287-019-1166-4.

    PMID: 30795797DERIVED

Related Links

MeSH Terms

Conditions

Intervertebral disc disease

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

January 1, 2010

Primary Completion

May 4, 2017

Study Completion

May 4, 2017

Last Updated

June 2, 2017

Record last verified: 2017-05

Locations

ES(1)