History of CRISPR Timeline

Researchers in China reported the birth of the first monkeys edited using CRISPR-Cas9, targeting genes involved in metabolism and immune regulation. The achievement demonstrated that CRISPR could be used to create genetically modified primates, raising both excitement and ethical concerns.

Researchers at UC San Diego and elsewhere demonstrated CRISPR-based gene drives capable of spreading genetic modifications through wild insect populations. The technology raised hopes for eliminating malaria-carrying mosquitoes while prompting concerns about ecological risks.

Image source: Gene drive

Oncologist Lu You in Chengdu treated the first human patient with CRISPR-edited cells, injecting T cells engineered to knock out PD-1 into a lung cancer patient, making China the first country to administer a CRISPR-based therapy to a person.

A team at the University of Pennsylvania launched the first U.S. clinical trial using CRISPR-Cas9, modifying patients' T cells ex vivo to fight cancer by disabling PD-1 and engineering cells to target tumors, marking CRISPR's entry into American human medicine.

Shoukhrat Mitalipov's team at Oregon Health & Science University reported successfully correcting the MYBPC3 gene mutation responsible for hypertrophic cardiomyopathy in viable human embryos, though subsequent analyses questioned some of the findings, intensifying scrutiny of embryo editing.

Image source: Assisted reproductive technology

Vertex Pharmaceuticals and CRISPR Therapeutics dosed the first patient with CTX001, an experimental therapy editing blood stem cells to treat sickle cell disease. The patient became free of severe pain crises, heralding the promise of curative CRISPR therapies.

Image source: CRISPR Therapeutics

Researchers including Feng Zhang and Doudna adapted CRISPR systems such as SHERLOCK and DETECTR into rapid diagnostic tests for SARS-CoV-2 during the pandemic, showcasing CRISPR's utility beyond gene editing in molecular detection.

Editas Medicine reported preliminary data from the BRILLIANCE trial, the first attempt to deliver CRISPR directly inside the human body. Patients with inherited blindness received subretinal injections of CRISPR components designed to edit the CEP290 gene in retinal cells.

Vertex Pharmaceuticals and CRISPR Therapeutics advanced exa-cel (CTX001) through late-stage clinical trials, reporting continued positive results for both sickle cell disease and beta thalassemia, positioning it to become potentially the first approved CRISPR-based medicine.

Intellia Therapeutics and Regeneron published landmark Phase 1 data showing that a single intravenous infusion of NTLA-2001, a lipid nanoparticle delivering CRISPR machinery to the liver, dramatically reduced levels of transthyretin protein in patients with amyloidosis — proving systemic in vivo CRISPR editing was possible.

Image source: Intellia Therapeutics

The Broad Institute was awarded foundational U.S. patents for CRISPR-Cas9 applications in eukaryotic cells under a fast-track process, igniting a high-stakes patent dispute with the University of California over who deserved credit and control of the lucrative technology.

Image source: CRISPR gene editing

A team led by Junjiu Huang at Sun Yat-sen University reported editing the HBB gene in nonviable human embryos using CRISPR, becoming the first study to modify human embryos. The work sparked global debate about the ethics of germline modification and calls for moratoriums.

Image source: He Jiankui affair

The University of California filed an interference proceeding against the Broad Institute's CRISPR patents, launching one of the most consequential scientific patent battles in history, known informally as the 'CRISPR war' between teams associated with Doudna and Zhang.

Scientists, ethicists, and policymakers gathered in Washington, D.C., for the first International Summit on Human Gene Editing, organized partly in response to Chinese embryo-editing work. The summit concluded that germline editing should not proceed until safety and ethical issues were resolved.

The USDA determined that a CRISPR-edited white button mushroom developed at Penn State did not require regulatory approval because it contained no foreign DNA, setting an important precedent for lighter regulation of gene-edited agricultural products in the United States.

Image source: Regulation of genetic engineering

A National Academies of Sciences and National Academy of Medicine report concluded that clinical trials of heritable germline editing could be permitted in narrow circumstances once stringent safety and ethical conditions were met, providing a framework for future policy debates.

Image source: Human genetic enhancement

Chinese scientist He Jiankui shocked the world by announcing the birth of twin girls whose genomes he had edited with CRISPR to resist HIV infection. He was widely condemned by the scientific community and later sentenced to prison for illegal medical practice, triggering international calls for stricter oversight.

In response to the He Jiankui scandal, the WHO established an expert advisory committee to develop global standards and governance frameworks for human genome editing, aiming to prevent rogue experimentation and coordinate international oversight.

Image source: World Health Organization

The World Health Organization issued its first comprehensive recommendations on human genome editing, urging countries to establish registries of trials, strengthen oversight, and prohibit unsafe or unethical experiments following two years of expert consultation.

Image source: Genome editing

The U.S. Patent Trial and Appeal Board ruled that the Broad Institute's patents for CRISPR-Cas9 in eukaryotic cells were distinct from earlier University of California claims, a major victory for the Zhang-associated team, though appeals continued afterward.