Clinical_trial Embryonic_stem_cell

on january 23, 2009, phase clinical trials transplantation of oligodendrocytes (a cell type of brain , spinal cord) derived human es cells spinal cord-injured individuals received approval u.s. food , drug administration (fda), marking world s first human es cell human trial. study leading scientific advancement conducted hans keirstead , colleagues @ university of california, irvine , supported geron corporation of menlo park, ca, founded michael d. west, phd. previous experiment had shown improvement in locomotor recovery in spinal cord-injured rats after 7-day delayed transplantation of human es cells had been pushed oligodendrocytic lineage. phase clinical study designed enroll 8 ten paraplegics have had injuries no longer 2 weeks before trial begins, since cells must injected before scar tissue able form. researchers emphasized injections not expected cure patients , restore mobility. based on results of rodent trials, researchers speculated restoration of myelin sheathes , increase in mobility might occur. first trial designed test safety of these procedures , if went well, hoped lead future studies involve people more severe disabilities. trial put on hold in august 2009 due fda concerns regarding small number of microscopic cysts found in several treated rat models hold lifted on july 30, 2010.

in october 2010 researchers enrolled , administered ests first patient @ shepherd center in atlanta. makers of stem cell therapy, geron corporation, estimated take several months stem cells replicate , grnopc1 therapy evaluated success or failure.

in november 2011 geron announced halting trial , dropping out of stem cell research financial reasons, continue monitor existing patients, , attempting find partner continue research. in 2013 biotime (amex: btx), led ceo dr. michael d. west, acquired of geron s stem cell assets, stated intention of restarting geron s embryonic stem cell-based clinical trial spinal cord injury research.

biotime company asterias biotherapeutics (nyse mkt: ast) granted $14.3 million strategic partnership award california institute regenerative medicine (cirm) re-initiate world’s first embryonic stem cell-based human clinical trial, spinal cord injury. supported california public funds, cirm largest funder of stem cell-related research , development in world.

the award provides funding asterias reinitiate clinical development of ast-opc1 in subjects spinal cord injury , expand clinical testing of escalating doses in target population intended future pivotal trials.

ast-opc1 population of cells derived human embryonic stem cells (hescs) contains oligodendrocyte progenitor cells (opcs). opcs , mature derivatives called oligodendrocytes provide critical functional support nerve cells in spinal cord , brain. asterias presented results phase 1 clinical trial testing of low dose of ast-opc1 in patients neurologically-complete thoracic spinal cord injury. results showed ast-opc1 delivered injured spinal cord site. patients followed 2–3 years after ast-opc1 administration showed no evidence of serious adverse events associated cells in detailed follow-up assessments including frequent neurological exams , mris. immune monitoring of subjects through 1 year post-transplantation showed no evidence of antibody-based or cellular immune responses ast-opc1. in 4 of 5 subjects, serial mri scans performed throughout 2–3 year follow-up period indicate reduced spinal cord cavitation may have occurred , ast-opc1 may have had positive effects in reducing spinal cord tissue deterioration. there no unexpected neurological degeneration or improvement in 5 subjects in trial evaluated international standards neurological classification of spinal cord injury (isncsci) exam.

the strategic partnership iii grant cirm provide funding asterias support next clinical trial of ast-opc1 in subjects spinal cord injury, , asterias’ product development efforts refine , scale manufacturing methods support later-stage trials , commercialization. cirm funding conditional on fda approval trial, completion of definitive agreement between asterias , cirm, , asterias’ continued progress toward achievement of pre-defined project milestones.