Astellas Institute for Regenerative Medicine is a subsidiary of

Astellas Pharma is a Japanese multinational pharmaceutical company, formed on 1 April 2005 from the merger of and . On February 5, 2020, the company announced management changes effective from April 1, 2020. Astellas is a member of the Mitsubishi UFJ Finan ...

located in

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

, US, developing

stem cell therapies Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition. , the only established therapy using stem cells is hematopoietic stem cell transplantation. This usually takes the form of a bone-marrow transplantation, b ...

with a focus on diseases that cause

blindness Visual impairment, also known as vision impairment, is a medical definition primarily measured based on an individual's better eye visual acuity; in the absence of treatment such as correctable eyewear, assistive devices, and medical treatment� ...

. 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 and

Chief Executive Officer A chief executive officer (CEO), also known as a central executive officer (CEO), chief administrator officer (CAO) or just chief executive (CE), is one of a number of corporate executives charged with the management of an organization especial ...

. 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 central executive officer (CEO), chief administrator officer (CAO) or just chief executive (CE), is one of a number of corporate executives charged with the management of an organization especiall ...

. 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 federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(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 pluripotent stem cells derived from the inner cell mass of a blastocyst, an early-stage pre- implantation embryo. Human embryos reach the blastocyst stage 4–5 days post fertilization, at which time they cons ...

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 Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second ...

in February 2015.

Research

Macular degeneration

On November 30, 2010, Ocata filed an Investigational New Drug 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 pigmented cell layer just outside the neurosensory retina that nourishes retinal visual cells, and is firmly attached to the underlying choroid and overlying retinal visual ...

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 or no vision in the center of the visual field. Early on there are often no symptoms. Over time, however, som ...

(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 or no vision in the center of the visual field. Early on there are often no symptoms. Over time, however, som ...

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

U.S The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territor ...

. and

Europe Europe is a large peninsula conventionally considered a continent in its own right because of its great physical size and the weight of its history and traditions. Europe is also considered a subcontinent of Eurasia and it is located enti ...

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