FDA halts one of the first human CRISPR studies before it begins
Posted by btwatson on May 30, 2018 11:16 pm
Tags:
Categories:
Crispr Articles
Source: FDA halts one of the first human CRISPR studies before it begins

A trial planning to use the gene-editing tool CRISPR on sickle cell disease patients has been put on hold due to unspecified questions from US regulators.
Background: CRISPR Therapeutics, which is developing the therapy, sought approval from the US Food and Drug Administration in April to begin the study. The therapy involves extracting stem cells from a patient’s bone marrow and editing them with CRISPR in the lab. Once infused back into the patient, the idea is that the edited cells would give rise to healthy red blood cells.
FDA hold: But according to a statement on Wednesday from CRISPR Therapeutics, the FDA ordered the company not to proceed with its study until it answers questions about its CRISPR treatment (the company didn’t provide any further details about what those questions are, however).
The FDA did not immediately respond to a request for comment.
Planned trials: CRISPR Therapeutics says a European trial for the inherited blood disorder beta thalassemia, which involves a similar procedure, won’t be affected by the FDA’s order. The company plans to begin that study in the second half of the year.
Separately, the first CRISPR trial in the US, conducted by the University of Pennsylvania, is currently enrolling patients.
Image credit:
- American Thoracic Society
Published at Wed, 30 May 2018 23:04:02 +0000
Crispr News
-
Could CRISPR gene editing raise cancer risks? - Genetic Literacy ProjectAugust 9, 2022
-
Plant Breeding and CRISPR Plants Market 2022 Upcomming Big Trends | Bayer, Syngenta, KWS, DowDuPont – Shanghaiist - ShanghaiistAugust 9, 2022
-
Crispr: My Long Term 'Wait And Watch' Punt On The Future Of Gene Editing (NASDAQ:CRSP) - Seeking AlphaAugust 8, 2022
-
New portable diagnostic detects SARS-CoV-2 RNA and antibodies at the same time - EurekAlertAugust 8, 2022
-
CRISPR Therapeutics GAAP EPS of -$2.40 misses by $0.19, revenue of $0.16M misses by $2.04M (NASDAQ:CRSP) - Seeking AlphaAugust 8, 2022
-
CRISPR THERAPEUTICS AG Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) - Marketscreener.comAugust 8, 2022
-
Pfizer bets $5.4bn against gene therapies in sickle cell - Evaluate PharmaAugust 8, 2022
-
Epigenic Therapeutics raises $20M for gene editing technology - Labiotech.euAugust 8, 2022
-
Episode 11 - CRISPR with Dr Jakob Haaber & Dr Richard Fox - Drug Target ReviewAugust 8, 2022
-
CRISPR and Cas Genes Market Size, Scope, Growth Opportunities, Trends by Manufacturers And Forecast to 2029 – Shanghaiist - ShanghaiistAugust 8, 2022
-
Vertex: Q2 2022 Earnings Steady - But Expect Volatility Soon (NASDAQ:VRTX) - Seeking AlphaAugust 5, 2022
-
New Products Posted to GenomeWeb: Thermo Fisher, Seer, Novacyt, Artisan Bio, More - GenomeWebAugust 5, 2022
-
'TnpB protein, a new tool in CRISPR-Cas gene editing' - KBRAugust 5, 2022
-
Cancers and heart disease could be diagnosed more easily with new rapid test - Imperial College LondonAugust 4, 2022
-
Intellia Therapeutics Announces Second Quarter 2022 Financial Results and Highlights Recent Company Progress - Yahoo FinanceAugust 4, 2022
- CRISPR rivals put patents aside to help in fight against Covid-19 – STAT
- CRISPR 2.0: Base Editing in the Groove – Genetic Engineering & Biotechnology News
- The Promises of CRISPR Genome Editing in Biomedicine – Labiotech.eu
- The Code Breaker and Crispr People — the ethics of editing humanity – Financial Times
- ERS Genomics Licenses CRISPR Patents to CRO ZeClinics – GenomeWeb
- The Dark Side of CRISPR – Scientific American
- ERS Genomics and ZeClinics Sign CRISPR/Cas9 License Agreement – BioSpace
- Scientists Use CRISPR To Create Model of AML Progression – AJMC.com Managed Markets Network
- DECODR app identifies DNA mutations from CRISPR gene therapies – European Pharmaceutical Review
- CRISPR/Cas technology as a promising weapon to combat viral infections – Wiley
- Neanderthal-like ‘mini-brains’ created in lab with CRISPR – Nature.com
- Affordable CRISPR app reveals unintended mutations at site of CRISPR gene repair – Phys.org
- Affordable CRISPR app reveals unintended mutations at site of CRISPR gene repair – EurekAlert
- New CRISPR tech targets human genome’s complex code: Programmable CRISPR/Cas9-based kinase offers insights into, control over regulatory histone proteins – Science Daily
- After ditching Editas, AbbVie taps Caribou for new CRISPR, CAR-T pact – FierceBiotech