Clinical Trial on the Use of Autologous Bone Marrow Stem Cells in Amyotrophic Lateral Sclerosis (CMN/ELA)

F

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Status and phase

Completed
Phase 2
Phase 1

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Procedure: Autologous bone marrow cells collection
Procedure: Laminectomy and bone marrow stem cells transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT00855400
ISCIII: EC07/90762
EudraCT number: 2006-003096-12
CMN/ELA

Details and patient eligibility

About

The purpose of this clinical trial is to asses the feasibility and the security of the intraspinal infusion of autologous bone marrow stem cells for the treatment of Amyotrophic Lateral Sclerosis patients.

Full description

Patients with Amyotrophic Lateral Sclerosis (ALS) typically endure a progressive paralysis due to the continued loss of motoneurons that leads them to death in less than 5 years. No treatment has changed its natural history. Intraspinal injections of bone marrow mononuclear cells (MNC) have been able to ameliorate the course of ALS in murine models, acting as pumps of trophic factors that keep the motoneurons functional. We have designed a phase I/II clinical trial to check the feasibility of this approach in humans.

Enrollment

11 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnose established following the World Federation of Neurology criteria
  • More than 6 and less than 36 months of evolution of the disease
  • Medullar onset of the disease
  • More than 20 and less than 65 years old
  • Forced Vital Capacity equal or superior to 50%
  • Total time of oxygen saturation <90% inferior to 2% of the sleeping time
  • Signed informed consent

Exclusion criteria

  • Neurological or psychiatric concomitant disease
  • Need of parenteral or enteral nutrition through percutaneous endoscopic gastrostomy or nasogastric tube
  • Concomitant systemic disease
  • Treatment with corticosteroids, immunoglobulins or immunosuppressors during the last 12 months
  • Inclusion in other clinical trials
  • Unability to understand the informed consent

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

Transplant
Experimental group
Description:
T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation
Treatment:
Procedure: Laminectomy and bone marrow stem cells transplantation
Procedure: Autologous bone marrow cells collection

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems