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Israel: Therapeutic / Stem Cell

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Lightly Regulated

Gene therapy permitted and clinical trials ongoing.

Gene therapy is permitted, but must be approved by a human research advisory committee and  a dedicated advisory committee (made up of physicians, scientists, regulators and ethics experts) and must follow regulations outlined in the Genetic Information Law. The creation of embryos specifically for stem-cell research is banned, but researchers can use embryos left over from in vitro fertilization.

The 2000 Genetic Information Law regulates genetic testing and has been applied to cover gene therapy. Among other guidelines, the law stipulates that genetic tests must be done in facilities accredited by the Israeli Ministry of Health. Tests done outside of the country must receive special authorization. Clinical trials must be conducted in accordance with the Clinical Trials Procedure, which requires that an application be submitted to the Helsinki Committee (human research advisory committee) of the institution where the clinical trial will take place.

Some Israeli clinics do offer mitochondrial replacement therapy (MRT), a controversial procedure that has been used to correct genetic defects and boost success in pregnancies.

Products/Research

  • Neuropathic pain: In 2019, Stem Cell Medicine received funding from the Israeli Ministry of Economy for a gene therapy facility in Jerusalem. Gene editing to treat neuropathic pain was among the first products in development.
  • Muscular dystrophy: PTC Therapeutics, a US pharmaceutical company, developed a gene therapy to treat a specific type of Duchenne muscular dystrophy, a severe, progressive muscle disease. Approved in Israel as well as the EU, Iceland, Liechtenstein, Norway and South Korea.
  • Cancer: The Israeli-founded company Kite Pharma has developed a CAR T-cell therapy for lymphoma that has been approved in the US. VBL Therapeutics has completed clinical trials for stem cell therapy for ovarian cancer.
  • Age-related blindness: Cell Cure Neurosciences, based in Jerusalem, developed a stem cell treatment for age-related macular degeneration that causes blindness.
  • ALS: Researchers are recruiting patients in Israel for a stem cell clinical trial to treat patients with amyotrophic lateral sclerosis (ALS), a progressive neurological disorder.
  • CRISPR research: MilliporeSigma, a Merck company, approved to begin using CRISPR and other gene editing techniques for gene therapy in Israel.

Regulatory Timeline

2016: Israel’s parliament passes Amendment No. 3 to the Prohibition on Genetic Intervention (Human Cloning and Genetic Change in Reproductive Cells), maintaining the ban on germline gene editing.

2000: Genetic Information Law passed, regulating genetic testing and research.

1999: Israeli parliament passes the Prohibition on Genetic Intervention (Human Cloning and Genetic Change in Reproductive Cells) banning germline gene editing.

NGO Reaction

None

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

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Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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