Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

March 31, 2013

Conditions
Amyotrophic Lateral Sclerosis
Interventions
BIOLOGICAL

MSC-NTF cells transplantation (IM)

In early ALS subjects: Autologous MSC-NTF cells will be transplanted under mild anesthesia, intramuscularly into patients' clinically unaffected (or only mildly affected) upper arm biceps and triceps muscles according to a pre-designed grid. Intramuscular injections will be by a 26 gauge needle to a 1.5cm depth (ensuring that injection is into muscle and not adipose tissue). The patients will be injected at 24 sites with a total of 24 million cells

BIOLOGICAL

MSC-NTF cells transplantation (IT)

In progressive ALS subjects: Autologous MSC-NTF cells will be transplanted under mild anesthesia intrathecally(via a standard lumbar puncture)with a total of 60 million cells.

Trial Locations (1)

91120

Hadassah Medical Organization, Jerusalem

Sponsors
All Listed Sponsors
collaborator

Hadassah Medical Organization

OTHER

lead

Brainstorm-Cell Therapeutics

INDUSTRY