NCT00855400

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

Typical duration 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

February 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 2, 2010

Status Verified

December 1, 2010

Enrollment Period

2.7 years

First QC Date

March 3, 2009

Last Update Submit

December 1, 2010

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral SclerosisBone marrowStem cellsAutologousSafety

Outcome Measures

Primary Outcomes (1)

  • Forced vital capacity

    Every 3 months

Secondary Outcomes (2)

  • ALS-FRS, MRC and Norris scales

    Every 3 months

  • Absence of adverse events

    Every week / month depending on the study phase

Study Arms (1)

Transplant

EXPERIMENTAL

T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

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

Interventions

Laminectomy and bone marrow stem cells transplantationPROCEDURE

T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation

Transplant
Autologous bone marrow cells collectionPROCEDURE

Autologous bone marrow cells collection under sedation. Sixty mL are obtained and processed through a ficoll gradient.

Transplant

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Unability to understand the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Related Publications (1)

  • Blanquer M, Moraleda JM, Iniesta F, Gomez-Espuch J, Meca-Lallana J, Villaverde R, Perez-Espejo MA, Ruiz-Lopez FJ, Garcia Santos JM, Bleda P, Izura V, Saez M, De Mingo P, Vivancos L, Carles R, Jimenez J, Hernandez J, Guardiola J, Del Rio ST, Antunez C, De la Rosa P, Majado MJ, Sanchez-Salinas A, Lopez J, Martinez-Lage JF, Martinez S. Neurotrophic bone marrow cellular nests prevent spinal motoneuron degeneration in amyotrophic lateral sclerosis patients: a pilot safety study. Stem Cells. 2012 Jun;30(6):1277-85. doi: 10.1002/stem.1080.

    PMID: 22415951DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Officials

  • Jose Maria Moraleda Jiménez, M.D. Ph.D.

    Hospital Universitario Virgen de la Arrixaca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

February 1, 2007

Primary Completion

October 1, 2009

Study Completion

February 1, 2010

Last Updated

December 2, 2010

Record last verified: 2010-12

Locations

ES(1)