BioTime Reports Isolation of Seven Diverse Cartilage and Bone Cell Types From Human Embryonic Stem Cells ALAMEDA, Calif.--(BUSINESS WIRE)

Reports Isolation of Seven Diverse Cartilage and Bone Cell Types From

Human Embryonic Stem Cells

ALAMEDA, Calif.--(BUSINESS WIRE)--December 18, 2012--BioTime, Inc. (NYSE

MKT: BTX), a biotechnology company that develops and markets products in

the field of regenerative medicine, and its subsidiaries OrthoCyte

Corporation and LifeMap Sciences reported today a means of manufacturing

seven distinct types of cartilage, bone, and tendon cells from human

embryonic stem cells. The paper, scheduled to be published online (ahead

of print) at 1600 GMT today in the peer-reviewed journal Regenerative

Medicine, characterizes the seven cell types generated using

BioTime's proprietary PureStemTM technology. The

study compared the novel cells with adult stem cells, known as

mesenchymal stem cells (MSCs), and revealed properties of the new cell

lines that are suggestive of a wide array of future applications in the

practice of orthopedic medicine.

In the study published today, it was demonstrated that BioTime's cells,

which can be manufactured on an industrial scale, are progenitors to

diverse skeletal tissues of the human body. These cell lines bear

diverse molecular markers that distinguish them from each other and from

MSCs. The molecular markers of BioTime's cell lines suggest the lines

may therefore be applicable to the repair of different types of bone,

cartilage, and tendon for the treatment of degenerative diseases

afflicting these tissue types such as non-healing bone fractures,

osteoarthritis and degeneration of intervertebral discs, and tendon

Chronic orthopedic disorders such as osteoarthritis, degeneration of the

discs in the spine, osteoporosis, and tendon tears are among the leading

complaints and causes of disability in an aging society. The recent

isolation of new pluripotent stem cells such as human embryonic stem

(hES) cells and induced pluripotent stem (iPS) cells opens the door to

the manufacture of all of the cell types in the human body on an

industrial scale. These achievements in the emerging field of

regenerative medicine have made it feasible to introduce new modalities

of repairing these and other tissues in the body.

As promising as these new stem cells may be for eventual human tissue

repair, there has been little progress to date in identifying new ways

to generate pure populations of the diverse cellular components of the

human body using methods that are also compatible with industrial-scale

manufacture. To address this need, BioTime scientists developed a novel

and proprietary manufacturing process. These isolated PureStemTM

(previously ACTCellerateTM) cell lines allow

for the scale-up of more than 200 highly purified and identified cell

In today's publication, BioTime scientists reported on seven PureStemTM

cell lines representing diverse cells of the developing human skeleton.

One of these cell lines, 4D20.8, was previously shown by BioTime

scientists to exhibit site-specific markers of craniofacial mesenchyme,

and in particular, markers of proximal mandibular mesenchyme. This

tissue type is of significance in that it naturally produces one of the

strongest joint cartilages of the body. In today's report, this line was

compared to the BioTime's lines 7PEND24, 7SMOO32, E15, MEL2, SK11, SM30,

and to other commonly studied MSCs. BioTime's cell lines displayed

markers that indicated the cells were progenitors of diverse cartilage,

bone, and tendon cell types in the body.

There remains the need for safe methods of manufacturing cells at a high

degree of purity and site-specific identity, in addition to an

FDA-approvable combination with a matrix to facilitate the stable

transplantation of those cells into the body. BioTime's HyStem

technology is designed to be an effective means of transplanting

cells in an injectable liquid that can polymerize safely in the body

into a tissue construct. BioTime anticipates that during the first

quarter of 2013, a submission of a Phase I safety trial in humans will

be made to the appropriate European Committee for review and approval of HyStem

formulated for the delivery of autologous fat-derived cells for skin

applications, a product called Renevia . In today's

publication, the seven novel osteochondral cell lines were demonstrated

to be successfully differentiated in HyStem in

laboratory experiments, supporting the potential use of the product

together with these and other PureStemTM cell lines in

combination products.

The study's demonstration of the manufacture of diverse site-specific

tissue progenitors from pluripotent stem cells serves to highlight the

utility of LifeMap Discovery , a powerful new database that

provides a roadmap to the complex fabric of cells constituting the human

body. In today's publication, BioTime and LifeMap scientists

collaborated to map the molecular markers of the published PureStemTM

cell lines within the database, thus making the lines available

for the research community in the context of the human developmental

"We are gratified to finally report in a scientific publication the

power of monoclonal human embryonic progenitor cell lines to scale

diverse cell types of the human body," said Michael D. West, Ph.D.,

BioTime's Chief Executive Officer. "Our confidence that many other cell

types of the human body can be manufactured in this manner is the reason

for our focus on this platform and for participating in building LifeMap

DiscoveryTM to help the medical research community

navigate this fascinating yet complex network of product development."

Arnold Caplan, Ph.D., OrthoCyte's Chief Scientific Officer and Director

of the Skeletal Research Center at Case Western Reserve University,

commented that the paper by Sternberg and colleagues "emphasizes the

scalability of clonal human embryonic stem cell-derived cell lines for

musculoskeletal tissue engineering. The analysis at the molecular level

of the biological markers gives us confidence that these groups of cells

can be used for cartilage repair and regeneration. The amount of cells

that can be generated is really practical for human

musculoskeletal tissue regeneration."

A discussion of OrthoCyte's product development strategy delivered by

Dr. Caplan and comments on the implications of BioTime's scientific

advances are available online at www.biotimeinc.com and www.orthocyte.com.

Authors of today's publication include Hal Sternberg, Jennifer Kidd,

James T. Murai, Jianjie Jiang, Isaac E. Erickson, Walter D. Funk, Karen

B. Chapman, and Michael D. West of BioTime and OrthoCyte Corporation;

Ariel Rinon of LifeMap Sciences; and C. Thomas Vangsness, Jr., of the