A Dose-escalation Safety Trial for Intrathecal Autologous Mesenchymal Stem Cell Therapy in Amyotrophic Lateral Sclerosis

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

January 31, 2019

Study Completion Date

January 31, 2019

Conditions
Amyotrophic Lateral Sclerosis
Interventions
BIOLOGICAL

autologous mesenchymal stem cells

"There will be five treatment groups of up to five patients each. Groups 1, 2 and 4 will receive a single dose of cells. Groups 3 and 5 will receive 2 doses of cells separated by one month. Intrathecal injections into new subjects will be timed so that there is a minimum of one week between subject injections. The cell dose per group is as follows:~* Group 1: single intrathecal dose of 1 x 107 cells~* Group 2: single intrathecal dose of 5 x 107 cells~* Group 3: one intrathecal dose of 5 x 107 cells followed one month later by a second intrathecal dose of 5 x 107 cells~* Group 4: single intrathecal dose of 1 x 108 cells~* Group 5: one intrathecal dose of 1 x 108 cells followed one month later by a second intrathecal dose of 1 x 108 cells"

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER