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Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease

T

The Cellular Therapy Network (TerCel)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Intervertebral Disc Disease

Treatments

Procedure: Instrumented posterolateral arthrodesis

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01513694
CSM/Fusión/2009

Details and patient eligibility

About

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).

Enrollment

15 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

MSC seeded onto a phosphate ceramic
Experimental group
Description:
Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.
Treatment:
Procedure: Instrumented posterolateral arthrodesis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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