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Policy & Ethics Guidelines

The following are current Stem Cell policies and ethical guidelines:


The American Association for the Advancement of Science
The AAAS site includes numerous resources related to stem cell scientific, ethical, and policy issues, including the findings and recommendations of the AAAS/ICS Report on Stem Cell Research.

The National Academies
The National Academies’ Guidelines for Human Embryonic Stem Cell Research can be found at this site, along with several other free publications related to stem cell science and policy.

The National Institute of Health
The NIH resource for stem cell research website provides information and numerous documents related to the federal policies associated with human embryonic stem cell research.

The California Institute for Regenerative Medicine
The CIRM website contains information about the California Stem Cell Research and Cures Act (California/Prop 71).

The Science Network’s Stem Cell Symposium
The Science Network has archived webcasts from their symposium “Stem Cells: Science Ethics and Politics and the Crossroads”

Online Protocols

Below are links to Embryonic Stem Cell and Adult Stem Cell online protocols:

Embryonic Stem Cells

National Stem Cell Bank (NSCB)
Standard Operating Procedures (SOPs) used for the production and testing of cell lines distributed by the NSCB.

WiCell Research Institute
Protocols followed in the WiCell production and distribution laboratory to successfully grow and expand hESC lines.

Cold Spring Harbor Protocols
New and classic research techniques for ESC research, with a searchable database.

Current Protocols in Stem Cell Biology
Online edition of the laboratory manual from Wiley InterScience, updated monthly.  Subscription required.

Thomson Lab Protocols
hESC, MEF, and iPS protocols from James Thomson’s lab at the University of Wisconsin.

University of California, San Francisco
Protocols used by the Human Embryonic Stem Cell Biology Program to maintain their stem cell lines.

The Murine Embryonic Stem Cell Core, The Siteman Cancer Center
mESC protocols in use at the Washington University School of Medicine core facility.

Protocol Online
Research protocols in a variety of life science fields, contributed by researchers worldwide and collected from the web, with discussion forums.

Molecular Station
A compilation of ESC protocols from internet sources.

Protocols for isolation, characterization, Differentiation, and expansion of ESCs  from Invitrogen.

BresaGen, Inc. 2004 Methods Manual
Methods for culturing BresaGen’s hESC lines.

Geron Corporation Protocols
Protocols for the maintenance of hESCs in Feeder Free Conditions

Adult Stem Cells

Cold Spring Harbor Protocols
New and classic research techniques for stem cell research, with a searchable database.

Current Protocols in Stem Cell Biology
Online edition of the laboratory manual, updated monthly.  Subscription required.

Protocol Online
Research protocols in a variety of life science fields, contributed by researchers worldwide and collected from the web, with discussion forums.

The National Human Neural Stem Cell Resource
Stem cell harvest protocols used at the National Human Neural Stem Cell Resource, providing neural stem cells harvested from the post-natal, post-mortem, human brain to the research community.  

Protocols for isolation, characterization, differentiation, and expansion of adult stem cells from Invitrogen.

R&D Systems Protocols
Methods and products from R&D Systems.

To have your online protocols included in our list, please email your website to the Portal Editor.

Combinatorial Incorporation of Enhancer Blocking Components of the Chicken ß-Globin 5'HS4 and H

Combinatorial Incorporation of Enhancer Blocking Components of the Chicken β-Globin 5'HS4 and Human T-Cell Receptor α/δ BEAD-1 Insulators in Self-Inactivating Retroviral Vectors Reduces their Genotoxic Potential

Ali Ramezani, Teresa S. Hawley, Robert G. Hawley

Stem Cells Express, first published online September 11, 2008; doi:10.1634/stemcells.2008-0258



Insertional mutagenesis by retroviral vectors has emerged as a serious impediment to the widespread application of hematopoietic stem cell gene transfer for the treatment of hematologic diseases. Here we report the development of a 77-bp element, FII/BEAD-A (FB), which contains the minimal enhancer blocking components of the chicken β-globin 5'HS4 insulator and a homologous region from the human T-cell receptor α/δ BEAD-1 insulator. With a new flow cytometry-based assay, we show that the FB element is as effective in enhancer blocking activity as the prototypical 1.2-kb 5'HS4 insulator fragment. When incorporated into the residual U3 region of the 3' long terminal repeat (LTR) of a self-inactivating (SIN) gammaretroviral vector, the FB element was stably transferred to the 5' LTR during reverse transcription, flanking the integrated transgene expression cassette. Notably, using a recently established in vitro insertional mutagenesis assay involving primary murine hematopoietic cells, we found that SIN gammaretroviral vectors as well as SIN lentiviral vectors containing the FB element exhibited greatly reduced transforming potential—to background levels under the experimental conditions used—compared to their unshielded counterparts. These results suggest that the FB element-mediated enhancer blocking modification is a promising approach to dramatically improve the safety of retroviral vectors for therapeutic gene transfer.


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Endogenous Matrix Metalloproteinase (MMP)-3 and MMP-9 Promote the Differentiation and Migration of A

Endogenous Matrix Metalloproteinase (MMP)-3 and MMP-9 Promote the Differentiation and Migration of Adult Neural Progenitor Cells in Response to Chemokines

Basam Z. Barkho, Ari E. Munoz, Xuekun Li, Lu Li, Lee Anna Cunningham, Xinyu Zhao

Stem Cells Express, first published online September 25, 2008; doi:10.1634/stemcells.2008-0519



Adult neurogenesis is regulated by both intrinsic programs and extrinsic stimuli. The enhanced proliferation of adult neural stem/progenitor cells (aNPCs) in the subventricular zone and the migration of neuroblasts towards the ischemic region in adult brains present a unique challenge as well as an opportunity to understand the molecular mechanisms underlying the extrinsic cue-induced neurogenic responses. Matrix metalloproteinases (MMPs) are a family of proteinases known to play a role in extracellular matrix remodeling and cell migration. However, their presence in aNPCs and their potential function in injury-induced aNPC migration remain largely unexplored. Here we demonstrate that in response to two injury-induced chemokines, stromal cell-derived factor 1 (SDF-1) and vascular endothelial growth factor (VEGF), aNPCs differentiated into migratory cells that expressed increased levels of MMP-3 and MMP-9. While differentiated neuroblasts and a subpopulation of astrocytes migrated towards the chemokines, undifferentiated progenitors did not migrate. Blocking the expression of MMP-3 or MMP-9 in aNPCs interfered with both the differentiation of aNPCs and chemokine-induced cell migration. Thus, endogenous MMPs expressed by aNPCs are important for mediating their neurogenic response to extrinsic signals.


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SOX2 Silencing in Glioblastoma Tumor Initiating Cells Causes Stop of Proliferation and Loss of Tumor

SOX2 Silencing in Glioblastoma Tumor Initiating Cells Causes Stop of Proliferation and Loss of Tumorigenicity

Rosaria Maria Rita Gangemi, Fabrizio Griffero, Daniela Marubbi, Marzia Perera, Maria Cristina Capra, Paolo Malatesta, Gian Luigi Ravetti, Gian Luigi Zona, Antonio Daga, Giorgio Corte

Stem Cells Express, first published online October 23, 2008; doi:10.1634/stemcells.2008-0493



Glioblastoma, the most aggressive cerebral tumor, is invariably lethal. Glioblastoma cells express several genes typical of normal neural stem cells. One of them, SOX2, is a master gene involved in sustaining self-renewal of several stem cells, in particular of neural stem cells. To investigate its role in the aberrant growth of glioblastoma, we silenced SOX2 in freshly derived glioblastoma tumor initiating cells (TICs). Our results indicate that SOX2 silenced glioblastoma TICs, despite the many mutations they have accumulated, stop proliferating and lose tumorigenicity in immunodeficient mice. SOX2 is then fundamental for maintenance of self-renewal capacity of neural stem cells also when they have acquired cancer properties. SOX2, or its immediate downstream effectors, would then be an ideal target for glioblastoma therapy.


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Human Embryonic Stem Cell Differentiation Toward Regional Specific Neural Precursors

Human Embryonic Stem Cell Differentiation Toward Regional Specific Neural Precursors

Slaven Erceg, Mohammad Ronaghi, Miodrag Stojkovic

Stem Cells Express, first published online October 9, 2008; doi:10.1634/stemcells.2008-0543


Human embryonic stem cells (hESC) are self renewing pluripotent cells which have the capacity to differentiate into a wide variety of cell types. This potentiality represents a promising source to overcome many human diseases by providing an unlimited supply of all cell types including cells with neural characteristics. Therefore, this review summarises early neural development and potential of hESC to differentiate under in vitro conditions examining at the same time the potential use of differentiated hESC for therapeutic applications for neural tissue and cell regeneration.


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Epigenetic Reprogramming by Somatic Cell Nuclear Transfer in Primates

We recently demonstrated that somatic cells from adult primates could be reprogrammed into a pluripotent state by somatic cell nuclear transfer (SCNT). However, the low efficiency with donor cells from one monkey ......

Partnership for Stem Cells journal

Hoboken, NJ, and Durham, NC, July 28, 2008— Wiley-Blackwell, the scientific, technical, medical and scholarly publishing business of John Wiley & Sons, Inc. and AlphaMed Press today announced that Wiley-Blackwell has been selected to serve as co-publisher of Stem Cells.

First Human Clinical Trial of Embryonic Stem Cell-Based Therapy


Geron to Study GRNOPC1 in Patients with Acute Spinal Cord Injury

Video Illustration of GRNOPC1 in an Animal Model of Spinal Cord Injury

Video of GRNOPC1 Manufacturing

Webcast : Geron Discusses FDA Clearance

More about the GRNOPC1 Study -  Safety studies. manufacturing, intellectual property

More about Geron

Reuters Article



Geron News Release

MENLO PARK, Calif., January 23, 2009 - Geron Corporation (Nasdaq: GERN) announced today that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury.

The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man. Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.

"The FDA's clearance of our GRNOPC1 IND is one of Geron's most significant accomplishments to date," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."

GRNOPC1, Geron's lead hESC-based therapeutic candidate, contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005).

"The neurosurgical community is very excited by this new approach to treating devastating spinal cord injury," said Richard Fessler, M.D., Ph.D., professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. "Demyelination is central to the pathology of the injury, and its reversal by means of injecting oligodendrocyte progenitor cells would be revolutionary for the field. If safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."

The GRNOPC1 Clinical Program

Patients eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury. Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study.

Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established and the FDA reviews clinical data in conjunction with additional data from ongoing animal studies, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate.

Preclinical Evidence of Safety, Tolerability and Efficacy 

Geron submitted evidence of the safety, tolerability and efficacy of GRNOPC1 to the FDA in a 21,000-page IND application that described 24 separate animal studies requiring the production of more than five billion GRNOPC1 cells. Included in the safety package were studies that showed no evidence of teratoma formation 12 months after injection of clinical grade GRNOPC1 into the injured spinal cord of rats and mice. Other studies documented the absence of significant migration of the injected cells outside the spinal cord, allodynia induction (increased neuropathic pain due to the injected cells), systemic toxicity or increased mortality in animals receiving GRNOPC1.

In vitro studies have shown that GRNOPC1 is minimally recognized by the human immune system. GRNOPC1 is not recognized in vitro by allogeneic sera, NK cells or T cells (Journal of Neuroimmunology, Vol. 192, 2007). These immune-privileged characteristics of the hESC-derived cells allow a clinical trial design that incorporates a limited course of low-dose immunosuppression and provide the rationale for an off-the-shelf, allogeneic cell therapy.

Also included in the IND application were published studies supporting the utility of GRNOPC1 for the treatment of spinal cord injury. Those studies showed that administration of GRNOPC1 significantly improved locomotor activity and kinematic scores of animals with spinal cord injuries when injected seven days after the injury (Journal of Neuroscience, Vol. 25, 2005). Histological examination of the injured spinal cords treated with GRNOPC1 showed improved axon survival and extensive remyelination surrounding the rat axons. These effects of GRNOPC1 were present nine months after a single injection of cells. In these nine-month studies, the cells were shown to migrate and fill the lesion cavity, with bundles of myelinated axons crossing the injury site.

Production and Qualification of GRNOPC1

GRNOPC1 is produced using current Good Manufacturing Practices (cGMP) in Geron's manufacturing facilities. Geron's GRNOPC1 production process and clean-room suites have been inspected and licensed by the state of California. The cells are derived from the H1 human embryonic stem cell line, which was created before August 9, 2001. Studies using this line qualify for U.S. federal research funding, although no federal funding was received for the development of the product or to support the clinical trial.

Geron's H1 hESC master cell bank is fully qualified for human use and was shown to be karyotypically normal and free of measurable contaminants of human or animal origin. Production of GRNOPC1 from undifferentiated hESCs in the master cell bank uses qualified reagents and a standardized protocol developed at Geron over the past three years. Each manufacturing run of GRNOPC1 is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before release for clinical use. GRNOPC1 product that has passed all such specifications and has been released is available for the approved clinical trial. The current production scale can supply product needs through pivotal clinical trials. The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years.

Intellectual Property

The production and commercialization of GRNOPC1 is protected by a portfolio of patent rights owned by or exclusively licensed to Geron. Patent rights owned by Geron protect key technologies developed at Geron for the scalable manufacturing of hESCs, as well as the production of neural cells by differentiation of hESCs. The fundamental patents covering hESCs are exclusively licensed to Geron from the Wisconsin Alumni Research Foundation (WARF) for the production of neural cells, cardiomyocytes and pancreatic islets for therapeutic applications. The validity of these patents was recently confirmed by the U.S. Patent and Trademark Office in a re-examination proceeding. Geron funded the original research at the University of Wisconsin-Madison that led to the first isolation of hESCs. The production of oligodendrocytes from hESCs is covered by patent rights exclusively licensed to Geron from the University of California. These patent rights cover technology developed in a research collaboration between Geron and University of California scientists.

Conference Call and Video Webcast

Thomas B. Okarma, Ph.D., M.D., will host a conference call and video Webcast presentation for investors and the media at 6:00 a.m. PST/9:00 a.m. EST today. Participants can access the conference call via telephone by dialing 866-783-2145 (U.S.) or 857-350-1604 (international). The passcode is 89631672. The video Webcast presentation is available at All participants are encouraged to view Dr. Okarma's presentation on the Internet. The video Webcast will also be accessible through a link that is posted on the home page of Geron's Web site at Participants are encouraged to log on at least 15 minutes prior to the beginning of the presentation in order to download any necessary software. The video Webcast will be available for replay through February 23, 2009.

About Geron

Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials. Geron is also the world leader in the development of human embryonic stem (hESC) cell-based therapeutics. The company has received FDA clearance to begin the world's first human clinical trial of a hESC-based therapy: GRNOPC1 for acute spinal cord injury. For more information, visit

This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding potential applications of Geron's human embryonic stem cell technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron's periodic reports, including the quarterly report on Form 10-Q for the quarter ended September 30, 2008.



Media: David Schull, Russo Partners, LLC, 858-717-2310,
At Geron: Anna Krassowska, Investor and Media Relations, 650-473-7765,

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Stem Cells Used to Reverse Paralysis in Animals

Arrow imageeValencia, Spain – January 28, 2009 – A new study has found that transplantation of stem cells from the lining of the spinal cord, called ependymal stem cells, reverses paralysis associated with spinal cord injuries in laboratory tests. The findings show that the population of these cells after spinal cord injury was many times greater than comparable cells from healthy animal subjects. The results open a new window on spinal cord regenerative strategies. The study is published in the journal Stem Cells.


The transplanted cells were found to proliferate after spinal cord injury and were recruited by the specific injured area. When these cells were transplanted into animals with spinal cord injury, they regenerated ten times faster while in the transplant subject than similar cells derived from healthy control animals.


Spinal cord injury is a major cause of paralysis, and the associated trauma destroys numerous cell types, including the neurons that carry messages between the brain and the rest of the body. In many spinal injuries, the cord is not actually severed, and at least some of the signal-carrying nerve cells remain intact. However, the surviving nerve cells may no longer carry messages because oligodendrocytes, which comprise the insulating sheath of the spinal cord, are lost.


The regenerative mechanism discovered was activated when a lesion formed in the injured area. After a lesion formed in the transplant subject, the stem cells were found to have a more effective ability to differentiate into oligodendrocytes and other cell types needed to restore neuronal function.


Currently, there are no effective therapies to reverse this disabling condition in humans. However, the presence of these stem cells in the adult human spinal cords suggests that stem cell-associated mechanisms might be exploited to repair human spinal cord injuries.


Given the serious social and health problems presented by diseases and accidents that destroy neuronal function, there is an ever-increasing interest in determining whether adult stem cells might be utilized as a basis of regenerative therapies.


“The human body contains the tools to repair damaged spinal cords. Our work clearly demonstrates that we need both adult and embryonic stem cells to understand our body and apply this knowledge in regenerative medicine,” says Miodrag Stojkovic, co-author of the study. “There are mechanisms in our body which need to be studied in more detail since they could be mobilized to cure spinal cord injuries.”

This study is published in Stem Cells. Media wishing to receive a PDF of this article may contact .


To view the abstract for this article, please click here.


Miodrag Stojkovic, Ph.D., is the Deputy Director and Head of the Cellular Reprogramming Laboratory at Centro de Investigacion Principe Felipe. Dr. Stojkovic can be reached for questions by contacting


Stem Cells, a peer reviewed journal published monthly, provides a forum for prompt publication of original investigative papers and concise reviews. The journal covers all aspects of stem cells: embryonic stem cells/induced pluripotent stem cells; tissue-specific stem cells; cancer stem cells; the stem cell niche; stem cell epigenetics, genomics and proteomics; and translational and clinical research. For more information, please visit


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