Thursday, April 2, 2020

Tag: Asterias Biotherapeutics

Asterias Biotherapeutics Receives FDA Clearance to Enroll C-4 Patients in SCiStar Study

Published: July 10, 2017 | Spinal Cord Injury:

Ability to enroll patients with second most common cervical spinal cord injury broadens eligible population for SCiStar study and future trials

FREMONT, Calif., July 10, 2017 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s amendment to the clinical research protocol for its ongoing AST-OPC1 SCiStar Phase 1/2a clinical trial in motor complete cervical spinal cord injury (SCI). The amendment expands the eligibility criteria to include patients with a C-4 spinal cord injury and extends the dosing window from 14 to 30 days to 21 to 42 days post-injury.

Patients with Complete Paralysis Show Additional Recovery of Arm, Hand and Finger Function at...

Published: June 13, 2017

Third patient recovers two motor levels; three of six (50%) patients in AIS-A 10 million cell cohort have now recovered two motor levels on at least one side

FREMONT, Calif., June 13, 2017 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that new 9-month follow-up data from the AIS-A 10 million cell cohort in the company’s ongoing SCiStar Phase 1/2a clinical trial shows three of six (50%) patients have now recovered two levels of motor function and previously-announced improvements in arm, hand and finger function at 3-months and 6-months following administration of AST-OPC1 have been confirmed and further increased at 9-months.

Generating improvement in spinal cord injuries

Published: January 24, 2017

Early clinical trial results announced offer new hope in regenerative medicine

A new therapy to treat spinal cord injuries in people who have lost all motor and sensory function below the injury site shows additional motor function improvement at 6-months and 9-months following treatment with 10 million AST-OPC1. The positive efficacy results from an ongoing research study were announced on Jan. 24 in a conference held by Asterias Biotherapeutics, Inc., the biotechnology company that manufactures AST-OPC1.

Asterias stem cell therapy shows promise in spinal cord paralysis: U.S. study

Published: September 14, 2016

asterias-biotherapeuticsAn experimental stem cell therapy developed by Asterias Biotherapeutics restored some movement to patients paralyzed by recent spinal cord injuries, according to interim data from a small study being presented on Wednesday.

One of the five patients in the trial regained use of both arms and hands, and is now able to feed himself, send texts on a phone and operate a wheelchair, the Fremont, California-based company said.

Three months after the cells were implanted, the study met its efficacy goal of two patients regaining return of two motor levels of functioning on at least one side of their body, the company said.

All five people in the study have experienced some upper extremity improvement so far, Asterias said.

Paralyzed Man Regains Use of Arms and Hands After Experimental Stem Cell Therapy at...

Published: September 7, 2016 | Spinal Cord Injury:

neurosurgery-stem-cell-spine-patient-kris-boesenInitial Results Offer Hope for Patients to Reclaim Independence After Suffering Severe Spinal Injury

LOS ANGELES, Sept. 7, 2016 /PRNewswire/ — Keck Medical Center of USC today announced that a team of doctors became the first in California to inject an experimental treatment made from stem cells, AST-OPC1, into the damaged cervical spine of a recently paralyzed 21-year-old man as part of a multi-center clinical trial.

Stem Cell Agency Spinal Cord Injury Clinical Trial Passes Safety Hurdles

Published: August 31, 2016 | Spinal Cord Injury: , ,

logo-CIRMOakland, CA – A clinical trial using stem cells to treat people with recent spinal cord injuries has cleared two key safety hurdles, and been given approval to expand the therapy to a larger group of patients with a much higher dose of cells.

Asterias Biotherapeutics announced that its Data Monitoring Committee (DMC) has reviewed the safety data from the first two groups of patients treated and found no problems or adverse side effects. One group of three patients was given 2 million cells. The second group of five patients received 10 million cells. Asterias is now cleared to enroll another 5-8 patients with 20 million cells.

StemCells Inc says spinal injury therapy shows promise

Published: November 19, 2015

experimental stem cell therapyStemCells Inc said its experimental stem cell therapy improved the functioning and strength of limbs in patients with spinal cord injuries, becoming the second company to report promising data on the treatment for such injuries.

StemCells Inc said its experimental stem cell therapy improved the functioning and strength of limbs in patients with spinal cord injuries, becoming the second company to report promising data on the treatment for such injuries.

The Race To Treat Spinal Cord Injury: A Comparative Analysis

Published: July 16, 2015

Summary

  • Four biotech companies are pursuing the treatment of spinal cord injury with the use of stem cell transplantation.
  • Each company demonstrated efficacy in pre-clinical studies.
  • The race is in the early stages but InVivo Therapeutics is clearly leading the pack based on its strategic approach to accelerated HDE approval and initial trial results.

Asterias begins enrollment for AST-OPC1 Phase 1/2a trial to treat complete cervical spinal cord...

Published: March 5, 2015

ast_opc1Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a leading biotechnology company in the emerging field of regenerative medicine, announced today that Atlanta-based Shepherd Center, one of the nation’s top rehabilitation hospitals for spinal cord injury and brain injury, has commenced enrollment for the Phase 1/2a clinical trial of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI).

The Phase 1/2a trial follows the successful completion of the Phase 1 trial of AST-OPC1, which met its primary endpoints of safety and feasibility when administered to five patients with neurologically complete, thoracic SCI.

Stem cell trial for spinal cord injuries cleared by FDA

Published: August 27, 2014

michael-west-asteriasAn experimental treatment using controversial embryonic stem cells to fix severe spinal cord injuries has new life under a new company.

Asterias Biotherapeutics Inc. of Menlo Park received Food and Drug Administration clearance Wednesday to go forward with a 13-person safety study of so-called oligodendrocyte progenitor cells, or OPCs. Those cells, derived from embryonic stem cells, are thought to stimulate the growth of new nerve cells around the spinal cord and could help paralyzed patients regain movement.

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