Clinical trial of human embryonic stem cell therapy in US

by Poonam Singhal



Geron Corporation (Nasdaq: GERN) announced the enrollment of the first patient in the company's clinical trial of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells, GRNOPC1.

The primary objective of this Phase I study is to assess the safety and tolerability of GRNOPC1 in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries.

Participants in the study must be newly injured and receive GRNOPC1 within 14 days of the injury.

The patient was enrolled at Shepherd Center, a 132-bed spinal cord and brain injury rehabilitation hospital and clinical research center in Atlanta, GA. Shepherd Center is one of seven potential sites in the United States that may enroll patients in the clinical trial.

"Initiating the GRNOPC1 clinical trial is a milestone for the field of human embryonic stem cell-based therapies," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "When we started working with hESCs in 1999, many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials. This accomplishment results from extensive research and development and a succession of inventive steps to enable production of cGMP master cell banks, scalable manufacture of differentiated cell product, and preclinical studies in vitro and in animal models of spinal cord injury, leading to concurrence by the FDA to initiate the clinical trial."

"We are pleased to have our patients participating in this exciting research," said Donald Peck Leslie, M.D., medical director, Shepherd Center. "Our medical staff will evaluate the patients' progress as part of this study. We look forward to participating in clinical trials that may help people with spinal cord injury."

David Apple, M.D., Shepherd Center's medical director emeritus and principal investigator of the trial at Shepherd Center, said, "This clinical trial represents another step forward in Shepherd Center's involvement in an attempt to find a cure for paralysis in people with spinal cord injury. Shepherd Center is an ideal place to conduct this study because of our clinical expertise and the volume of patients referred here for rehabilitation care."

In addition to Shepherd Center, Northwestern Medicine in Chicago, IL is also open for patient enrollment. As additional trial sites come online and are ready to enroll patients, they will be listed on the Patient Information pages of Geron's website and on the NIH clinical trials registry, ClinicalTrials.gov.

Further information on the criteria for patient eligibility for the study is also available on ClinicalTrials.gov.


(Poonam Singhal -- sub-editor compiled and published Clinical trial of human embryonic stem cell therapy in US at HealthNewsTrack on October 11, 2010 sourced from Geron - http://www.geron.com/)

Stem cell therapy - recent articles and current news stories:

- Understanding beginnings of embryonic stem cells helps predict the future
- Neural stem cell transplant may cure diabetes
- 2 types of stem cells are similar
- US can continue to fund embryonic stem cell research
- SOX2 gene acts as a stem cell gatekeeper, decides neural stem cell fate

Most related articles:

- Clinical trial of human embryonic stem cell therapy in US
- US can continue to fund embryonic stem cell research - 12.2
- 2 types of stem cells are similar - 12.2
- Stem cell therapy may prove valuable in paralysis - 11.9
- US cancer group AACR supports NIH stem cell research - 11.4
- US to continue stem cell research - 11.1

More related articles:

- Clinical trial, Human embryonic stem cell, Progenitor cell, Spinal Injury, Spinal cord injury, Stem cell therapy
- Human clinical trial of embryonic stem cell therapy approved - 34.5
- US can continue to fund embryonic stem cell research - 25.5
- US to continue stem cell research - 23.6
- Stem cell therapy offers hope for acute lung injury - 23.1

Stem cell therapy related articles:

- Stem cell therapy may prove valuable in paralysis - 9.3
- 2 types of stem cells are similar - 7.2
- US Stem Cell Bank has received all 21 cell lines - 6.6
- Stem cell funding for Parkinson's Disease - 6.5
- Graying hairs are signs of stress - 6.4

Stem cell therapy article/news source:

Read more health articles from Geron and health articles from USA.

Stem cell therapy - search related terms:

Clinical trial, Human embryonic stem cell, Progenitor cell, Spinal Injury, Spinal cord injury, Stem cell therapy,
Stem cell therapy books,

List health news, Health organizations, Health news world, Glossary, Best health articles, Featured     Go to top

The information provided on Health Newstrack is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician. We comply with the HONcode principles for trustworthy health information, and Health News Track is hon code accredited, verify here.
About us, Site map Privacy policy, Disclaimer
© 2007, 2008, 2009, 2010, 2011 HealthNewsTrack.com
3.26