Hadassah

Safety Success in Hadassah AMD Stem Cell Trial Presented at International Conference

Tuesday, Dec 20 2016

Stem Cell Transplant: delivery of hESC-derived RPE cells into the sub-retinal space, through a thin cannule.

Data from the first patient cohort of the Phase I/IIa Hadassah Medical Organization clinical trial with the stem cell product, OpRegen®, aimed at slowing the progression of the advanced form of dry age-related macular degeneration (dry-AMD), was presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) on Friday, December 2, 2016, in Rome, Italy.

OpRegen®, comprised of retinal pigment epithelial (RPE) cells derived from human embryonic stem cells, was developed by BioTime Inc’s subsidiary, Cell Cure Neurosciences Ltd., together with Key Developers Prof. Eyal Banin, Director of Hadassah’s Center for Retinal and Macular Degenerations and a leading investigator for this trial, and Prof. Benjamin Reubinoff, head of Hadassah’s Human Embryonic Stem Cell Research Center and Chief Scientific Officer of Cell Cure. “The cells were created without the use of animal-derived products through a proprietary directed differentiation process to produce a highly purified population of RPE cells,” explains Prof. Reubinoff.

Prof. Banin notes that OpRegen has been “administered successfully in the first cohort of patients, with no serious adverse events.” In addition, retinal imaging suggests that OpRegen RPE cells are able to engraft.

The study involves the evaluation of the safety of three different dose regiments of OpRegen. The first Phase I/IIa patient cohort received an initial targeted dose of 50,000 cells. The Data Safety Monitoring Board (DSMB), an independent group of physicians and medical experts which is closely monitoring the clinical trial, has thoroughly assessed the safety profile of the first cohort of subjects and given its recommendation that the company continue the trial with the second cohort at a higher dose of 200,000 cells.

Enrollment in the second cohort is expected to be completed by the end of 2016. Depending on the outcome of the DSMB’s review of the second patient cohort, approval to begin administering the 500,000 cell dosage to the third patient cohort could be provided early next year. In addition, BioTime reports, the first OpRegen United States clinical trial site is expected to be selected in the near future.

“We are looking forward to the opportunity to present data from the first patient cohort at ISOPT,” said Adi Mohanty, Co-Chief Executive Officer of BioTime. “OpRegen’s progress in the clinic is gaining momentum and we have already treated patients with 200,000 cell doses. It is in these higher cell dose cohorts where we believe OpRegen has the potential to demonstrate more meaningful clinical outcomes and we expect to start reporting on these data in early 2017. Our goal is to develop a treatment that can serve the millions of dry-AMD patients for whom there are currently no FDA-approved therapies.”

OpRegen had received “Fast Track” designation from the Food and Drug Administration for treatment of the advanced form of dry-AMD. Details of the trial and about a patient’s eligibility are available at https://clinicaltrials.gov/ with the following Identifier: NCT02286089 (dry-AMD).

Comments

No comments yet.
First Name
Email
Comment
Enter this word:

Related Stories

alt_text

Monday, Oct 9 2017

Honoring a Hadassah Leader's Legacy with Increased Breast Cancer Programming

Jill Stenzler-Engelman devoted 15 years to Hadassah's Check It Out® breast cancer awareness program in St. Petersburg, Florida. She taught breast self-exam and early detection at high schools, jails, and more. Her husband, Dr. Greg Engelman, said, “Jill loved to teach and loved educating young adults and adults on being proactive about their health.” Sadly, after a courageous 10-year battle, Jill died of ovarian cancer at age 53.

READ MORE ›
alt_text

Monday, Oct 9 2017

Dr. Tamar Elram Announcement

The administration of Hadassah Medical Organization is pleased to announce the selection of Dr. Tamar Elram as the new Director of the Hadassah Mount Scopus Hospital.

READ MORE ›
alt_text

Wednesday, Oct 4 2017

Hadassah Medical Organization Sends Top Adolescent Trauma Expert to Mexico to Aid Earthquake-Ravaged Victims

Hadassah has sent one of the world’s top experts on adolescent Post Traumatic Stress Disorder Syndrome (PTSD) to Mexico City.

READ MORE ›
alt_text

Wednesday, Oct 4 2017

National Board Member’s Grandbaby Saved by Hadassah Heart Specialists

Long-time National Board Member Helaine Ohayon has been a devoted supporter of the Hadassah Medical Organization for many a year.

READ MORE ›

Donation Questions

donorservices@hadassah.org

(800) 928-0685

Membership Questions

membership@hadassah.org

(800) 664-5646

Missions Department

missions@hadassah.org

(800) 237-1517

Contact Us

40 Wall Street

New York, NY 10005

support@hadassah.org

More ›

Show More