Astellas Institute for Regenerative Medicine is a subsidiary of Astellas Pharma located in

Marlborough, Massachusetts Marlborough is a city in Middlesex County, Massachusetts, United States. The population was 41,793 at the 2020 United States census, 2020 census. Marlborough became a prosperous industrial town in the 19th century and made the transition to high ...

, US, developing stem cell therapies with a focus on diseases that cause

blindness Visual or vision impairment (VI or VIP) is the partial or total inability of visual perception. In the absence of treatment such as corrective eyewear, assistive devices, and medical treatment, visual impairment may cause the individual difficul ...

. It was formed in 1994 as a company named Advanced Cell Technology, Incorporated (ACT), which was renamed to Ocata Therapeutics in November 2014. In February 2016 Ocata was acquired by Astellas for $379 million USD.

History

Advanced Cell Technology was formed in 1994 and was led from 2005 to late 2010 by William M. Caldwell IV,

Chairman The chair, also chairman, chairwoman, or chairperson, is the presiding officer of an organized group such as a board, committee, or deliberative assembly. The person holding the office, who is typically elected or appointed by members of the gro ...

and

Chief Executive Officer A chief executive officer (CEO), also known as a chief executive or managing director, is the top-ranking corporate officer charged with the management of an organization, usually a company or a nonprofit organization. CEOs find roles in variou ...

. Upon Mr. Caldwell's death on December 13, 2010, Gary Rabin, a member of ACT's board of directors with experience in investment and capital raising, assumed the role of Chairman and CEO. In 2007 the company's Chief Scientific Officer (CSO), Michael D. West, PhD, also founder of Geron left Ocata to join a

regenerative medicine Regenerative medicine deals with the "process of replacing, engineering or regenerating human or animal cells, tissues or organs to restore or establish normal function". This field holds the promise of engineering damaged tissues and organs by st ...

firm, BioTime as

CEO A chief executive officer (CEO), also known as a chief executive or managing director, is the top-ranking corporate officer charged with the management of an organization, usually a company or a nonprofit organization. CEOs find roles in variou ...

. In 2008, for $250,000 plus royalties up to a total of $1 million, the company licensed its "ACTCellerate" technology to BioTime. Robert Lanza was appointed CSO. On November 22, 2010, the company announced that it had received approval from the U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) to initiate the first human

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

using

embryonic stem cells Embryonic stem cells (ESCs) are Cell potency#Pluripotency, pluripotent stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-Implantation (human embryo), implantation embryo. Human embryos reach the blastocyst stage 4� ...

to treat retinal diseases. A preliminary report of the trial published in 2012, and a follow-up article was published in February 2015. In July 2014, Ocata announced that Paul K. Wotton, previously of Antares Pharma Inc (ATRS:NASDAQ CM), became President and Chief Executive Officer. On August 27, 2014, Ocata announced a 1-100 reverse stock split of its common stock. Ocata was listed on

NASDAQ The Nasdaq Stock Market (; National Association of Securities Dealers Automated Quotations) is an American stock exchange based in New York City. It is the most active stock trading venue in the U.S. by volume, and ranked second on the list ...

in February 2015.

Research

Macular degeneration

On November 30, 2010, Ocata filed an

Investigational New Drug The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical industry, pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug inte ...

application with the U.S. FDA for the first

using

to regenerate

retinal pigment epithelium The pigmented layer of retina or retinal pigment epithelium (RPE) is the pigment A pigment is a powder used to add or alter color or change visual appearance. Pigments are completely or nearly solubility, insoluble and reactivity (chemistry), ...

to treat Dry Age-Related

Macular Degeneration Macular degeneration, also known as age-related macular degeneration (AMD or ARMD), is a medical condition which may result in blurred vision, blurred or vision loss, no vision in the center of the visual field. Early on there are often no sym ...

(Dry AMD). Dry AMD is the most common form of

macular degeneration Macular degeneration, also known as age-related macular degeneration (AMD or ARMD), is a medical condition which may result in blurred vision, blurred or vision loss, no vision in the center of the visual field. Early on there are often no sym ...

and represents a market size of $25–30 Billion in the

U.S The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic of 50 U.S. state, states and a federal capital district, Washington, D.C. The 48 ...

. and

Europe Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east ...

Stargardt's disease

In November 2010 the FDA allowed Ocata to begin a Phase I/II human clinical trial to use its retinal pigment epithelium cell therapy to treat

Stargardt disease Stargardt disease is the most common inherited single-gene retinal disease. In terms of the first description of the disease, it follows an autosomal recessive inheritance pattern, which has been later linked to bi-allelic ABCA4 gene variants ...

, a form of inherited juvenile macular degeneration.

References

{{Authority control Astellas Pharma Biotechnology companies of the United States Stem cells Biotechnology companies established in 1994 Life sciences industry

History

Research

Macular degeneration

Stargardt's disease

See also

References