Hadassah

Placental Stem Cell Therapy to Treat Acute Radiation Syndrome Receives Boost from FDA

Tuesday, Oct 24 2017

Prof. Raphael Gorodetsky

In collaboration with Pluristem Therapeutics, the Hadassah Medical Organization developed a stem cell product from the human placenta to prevent and treat acute radiation syndrome (ARS). The product, PLX-R18, has just received orphan drug status from the U.S. Food and Drug Administration (FDA).

“Receiving orphan drug designation brings us one step closer to providing a next-generation medical countermeasure against ARS,” notes Zami Aberman, Co-Chief Executive Officer and Chairman of Pluristem.

As Pluristem explains: The designation involves close guidance by the FDA, which may accelerate the path to potential marketing approval; orphan drug grants; tax credits; and seven-year market exclusivity upon marketing approval.

ARS (sometimes known as radiation toxicity or radiation sickness) is an acute lethal illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a very short period of time. The syndrome affects the body’s ability to form new blood cells (hematopoietic recovery). PLX therapy holds promise as a new treatment for cancer patients who suffer complications following high-dose radiation and chemotherapy.

The earlier, less effective version of PLX cell therapy was tested initially at Hadassah on terminally ill patients who had no other treatment option. The results were “very good,” reports Prof. Raphael Gorodetsky, head of the Biotechnology and Radiobiology Laboratory in Hadassah’s Sharett Institute of Oncology.

Pluristem recently reported positive data from non-human primate studies of PLX-R18 treatment for ARS. Conducted by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health (NIH), the study revealed improvement in survival rates and the enhancement of recovery across all three major blood lineages: white blood cells, red blood cells, and platelets.

Pluristem reports also that PLX-R18 cells are being studied by the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute to examine the effectiveness of the cells as a treatment for ARS prior to, and within the first 24 hours of, exposure to radiation. Pluristem PLX-R18 cells are also being studied by Fukushima Medical University in Japan for the treatment of ARS and as an adjunct to radiotherapy in cancer patients.

A clinical trial at Hadassah with PLX-R18 is now in the planning stages, Prof. Gorodetsky relates. 

Learn more about the Hadassah Medical Organization.

Comments

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

Related Stories

alt_text

Wednesday, Jun 12 2019

Multinational Study Reveals Reduction in Kidney Disease Progression with Diabetes Drug

In a large multinational study that revealed the effectiveness of a medicine called dapagliflozin in reducing cardiovascular death from heart failure among high-risk diabetic patients, the first sub-analysis of renal data has also identified a 47 percent drop in decline of kidney function and renal death.

READ MORE ›
alt_text

Wednesday, Jun 5 2019

What Causes PMS? Hadassah Study Offers Answer, with Implications for Future Research

A new explanation for the mood swings, irritability, and depression, known as Premenstrual syndrome (PMS) has been suggested by a Hadassah Medical Organization study.

READ MORE ›
alt_text

Wednesday, Jun 5 2019

Hadassah Confronts the Comeback of Measles

Measles, a disease we have not seen for a long time, has come back. In the past year and a half, Israel has seen over 4,000 cases, says Prof. Allon Moses, director of the Department of Clinical Microbiology and Infectious Diseases at the Hadassah Medical Organization.

READ MORE ›
alt_text

Wednesday, May 29 2019

First Cath Lab Opens in Northern Neighborhoods of Jerusalem at Hadassah Mount Scopus

Hadassah Hospital Mount Scopus inaugurated the first advanced cardiac catheterization unit serving Jerusalem’s northern neighborhoods.

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