STEM CELL THERAPIES
Since Ben’s diagnosis in 2002, Steve has traveled to at least eighteen countries in search of potential therapies. Patients have come to rely on his efforts to sort through pioneering efforts throughout the world - - not as a scientist, but as a father, friend, advocate and self-styled researcher. The internet is both a friend and a demon to ALS patients and their families because it offers a plethora of relevant, legitimate and valuable information as well as a host of disreputable and illegal offers. ALS patients and their families are most susceptible to being duped because of the desperation that surrounds their lives.
In 2004, Ben and Steve found themselves in China, wanting more than anything to believe in the Beijing promise, only to be later devastated and disappointed. In Steve’s words, “I wish I could say that my efforts have been fruitful, that there are off shore clinics effectively minimizing the symptoms of ALS through embryonic or adult stem cell therapy. Instead, I will say that there are some fine neuroscientists steadfastly working to find solutions to the perplexing issues facing their US colleagues. And others who are motivated by greed and have no scientific basis for their claims.”
The recent April 18, 2010 CBS 60 MINUTES broadcast, “21st Century Snake Oil Salesmen” unmasked the fraudulent claims of Frank Morales and Lawrence Stowe, two con men posing as licensed physicians claiming to cure ALS through $125,000 of worthless vitamins, supplements and a bogus stem cell procedure. Be sure to read the April 19 ALSWW newsletter for more information.
NEURALSTEM, INC.
Neuralstem, Inc. is a publicly traded biotherapeutics company whose mission is to apply stem cell research and its patented human neural stem cell technology to treat diseases of the central nervous system including Ischemic Paraplegia, Traumatic Spinal Cord Injury, ALS and Parkinson's Disease. Their stem cell research has resulted in a patented technology that allows them to produce mature, commercial quantities of neural stem cells with the ability to control the differentiation of the cells into physiologically relevant human neurons and glia. Once approved by the FDA, these cells could be transplanted into humans as treatments for currently incurable diseases.
The information that follows may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that many statements regarding potential applications of Neuralstem's technologies 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 Neuralstem's intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Neuralstem PDF
US FACILITIES
As of September 1, 2010, U.S. government officials say they will appeal a U.S. District Court injunction that stops new federal funding of human embryonic stem cell research. The ruling has no direct effect on researchers or companies working with private funds, but government funding often initiates the most basic, highest expense and riskiest biological work. Here is a partial list of companies currently working to develop both adult and embryonic stem cells as therapies:
Geron Corp recently received U.S. Food and Drug Administration approval to start testing its experimental human embryonic stem cell therapy in people with new spinal cord injuries -- the first trial of the controversial cells in humans.
StemCells Inc recently said its human neural stem cells helped improve movement in mice being treated for spinal injuries. The Palo Alto, California-based company plans to start human trials in 2011.
Advanced Cell Technology Inc recently received orphan drug status from the FDA for retinal stem cells to treat Stargardt's Macular Dystrophy, which can lead to blindness.
Neuralstem Inc said on Wednesday it has filed an investigational new drug application with the FDA to begin a Phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells. It is also testing its cells in patients with amyotrophic lateral sclerosis.
Aastrom Biosciences Inc is working on ways to take a patient's own cells and use them to treat heart disease. These are in advanced trials in patients.
Thermogenesis Corp supplies products and services that process and store adult stem cells. The company recently cut its workforce by 10% to lower expenses.
Osiris Therapeutics Inc is testing stem cells taken from bone marrow in patients with Crohn's disease and Graft vs Host Disease.
Cytori Therapeutics Inc uses its Celution system to take stem and regenerative cells from a patient's own fat tissue to form a fat graft to reconstruct and repair breast and soft tissue. It is not yet available in the United States.
ReNeuron Group PLC reported positive mouse data with its REN009 stem cell therapy for peripheral arterial disease in diabetes. It hopes to apply to start trials in people next year.
Aldagen Inc, a private company, announced results last year from a Phase I clinical trial of ALD-201, a stem cell treatment for heart failure. Many companies are working to find ways to use stem cells to regenerate damaged heart tissue.
Celgene Corp, better known for blood cancer treatments, has an experimental stem cell treatment for Crohn's disease in Phase I clinical trials.
International Stem Cell Corp in California is trying to make human stem cells via parthenogenesis, in which an unfertilized egg begins to divide and grow as if it were fertilized by sperm. It positions its potential products as alternatives to embryonic stem cells.
Hospital de Egaz Moniz
Dr. Carlos Lima
Rua da Junqueira 126
Lisbon, Portugal 1349-019
351-21-365-0001
crlima@clix.pt
Stem Cell PDF
Use of autologous olfactory cells through laminectomy and myelotomy 2001-2008 for successful spinal cord injury repair. Unique method harvests 25% of olfactory tissue, then dissected into small pieces and immersed into patient's cerebrospinal fluid, then implanted into spinal cord. Intends to begin with ALS patients in 2009. Plans to do so in other country due to Portuguese administrative delays. Estimated cost $40,000 - $50,000 US.
BrainStorm Cell Therapeutics Ltd.
Dr. Daniel Offen
Dr. Eldad Melamed
Tel Aviv University
12 Bazel St., POB 10019 Kiryat Aryeh
Petach Tikva, Israel 49001
110 East 59th Street
New York, NY 10022
212-557-9000
info@brainstorm-cell.com
www.brainstorm-cell.com
Adult autologous mesenchymal stem cell transfer using “NurOwn” technology that produces GDNF. 2003-2008 research efforts currently using rat models, recent collaboration with Bob Brown of Harvard Medical School. Recently began extraction and freezing of Israeli ALS patient bone marrow for intended culture and injection within next several months. No cost estimate available.
Beijing Rehabilitation Center
Beijing Hongtianji Neuroscience Academy
Dr. Hongyun Huang
Shijingshan District, Beijing 100144, China
86-10-51625952
hongyunh@gmail.com
www.nrrfr.com
www.lanr.org.en
Human olfactory ensheathing cells extracted from newly-aborted fetuses and cultured, then injected into cerebral frontal lobes and subarachoid space in spinal cord through lumbar puncture. Began procedure November 2003 and continues to present time. Widely criticized for lack of following and recording patient results, continuing procedures in face of negligible or little provable benefit. Significant percentage of patient death shortly after surgery. Estimated cost $22,000 US.
Beike Biotechnology Co, Ltd.
Dr. Sean Hu
W400, IER Building, South Area, Shenzhen Hi-Tech Industrial Park
Guangdong Province, China
86-755-86110575
877-2stemcells
Kirshner.ross@gmail.com
www.beikebiotech.com
Treatment protocol consists of multiple injections of stem cells extracted from human unbilical cord blood, injected both intravenously and through lumbar puncture and/or autologous mesenchymal cell transfer through lumbar puncture. Claims to have performed procedure on ALS patients since 2001 but I believe their first AL activity was in 2005 when they contacted me for support in their then-new efforts. Provides wide range of specific plans at costs from $20,000 - $40,000 US.
Sourasky Medical Center, Ichilov Building
Dr. Shimon Slavin
6 Weizman St. Tel Aviv 64239
011-972-3-697-4010
slavinmd@gmail.com
www.tasc.org.il
State of the art technologies to procure, select and manipulate blood, bone marrow and cord blood-derived stem cells and lymphocytes for adoptive cell-mediated immunotherapy of cancer, induction of transplantation tolerance to bone marrow and organ allografts and regulation of autoimmune diseases. Dr. Shimon Slavin, formerly of Hadassah University Hospital, Jerusalem, is a notable oncological surgeon. He has attempted 20-25 ALS procedures in 2004-2008 with little or no success, using autologous mesenchymal stem cell transfer injected both through IV and lumbar puncture. Extraction is done in Tel Aviv and implantation is thereafter done on an out-patient basis in Istanbul. Estimated cost $16,000 US.
Fundacion Don Roberto Fernandez Vina
Dr. Roberto Fernandez Vina
fundfernandezvina@hotmail.com
Miter 357, (2900) St. Nicholas
Buenos Aires, Argentina
3461-429968
Walter Trotter, contact
Dorauno44@hotmail.com
www.fundacionfernandezvina.org
Dr. Fernandez Vina is a notable cardiac surgeon practicing in Buenos Aires and authorized by the Ministry of Health to implant artificial hearts beginning in 2001. After pursuing an autologous mesenchymal cell transplant procedure through intravenous injection or catheter to treat cardiac disease, he recently expanded that procedure to treat ALS. He claims to have treated approximately 30 ALS patients between 2006 - 2008 with a “success ratio of 85%.” I feel the time frame is too short, the results unverified, and the success statement too vague to suggest any aggressive pursuit at this time. Patients are treated in both Buenos Aires and El Salvador. Further research continuing. Estimated cost $19,000 US.
X-Cell Center Institute for Regenerative Medicine
Eduardus Hospital Institute of Regenerative Medicine
Cologne, Germany
Dr. Cornelis Kleinbloesem
49-221-8025-095
J.D. Lenner, US contact
866-680-8282
jlennere@call-center.com
www.xcell-center.com
Autologous mesenchymal cell transplant through lumbar puncture. Claims to have treated approximately 60 ALS patients between 2004 - present with claimed improvement in 20 patients, no change in 16. Estimated cost $10,000 - $15,000 US. Research continuing.
EmCell
Dr. Alexander Smikodub
Kiev, Ukraine
38-044-249-7828
infocenter@emcell.com
www.emcell.com
Embryonic Stem Cell Transplants (ESCT) and autologous mesenchymal transplants through subcutaneous, intravenous and intrathecal injections. Claims to have successfully treated 62 ALS patients 1995 - present. Provides extensive, but highly subjective and unconfirmed, reports of successful treatment. Provides stem cells to other off-shore clinics. Estimated cost $16,000 - $24,000 US.
Hospital San Jose-TEC de Monterrey
Further information in greater detail is provided under the Treatment Section on this website.
TheraVitae Ltd. Life Sciences
Dr. Tzvi Stern, CEO
7 Pinhas Sapir Street
P.O. Box 4049
Ness Ziona, Israel 74410
972-8-909170
enquiries@theravitae.com
888-410-0920
www.theravitae.com
Through TheraVitae's patented VesCell technique, cells are isolated from the patient's own blood, processed outside of the body and then administered intravenously after significantly expanding the level of Angiogenic Cell Precursors (ACP's). Successfully trialed for heart disease, TheraVitae expects to use VesCell for ALS in 2009 with treatment in Thailand. Estimated cost $36,000 - $40,000 US.
Regina Mater Institute Clinic
Dr. Gustavo Moviglia
1777 Coronel Diaz, 5th Floor
Buenos Aires, Argentina 1245
The use of co-cultured stem cells with autoimmune T-cells injected intravenously. Approximately 5 - 10 patients treated 2004 - present, no reported positive results. Estimated cost is $50,000 - $125,000.
TriStem (London, UK) through
Healthcare Solutions International
Tariq Mumtaz, Managing Director
82/c, 3rd Floor
11th Commercial Street
DHA, Phase 11 Extension
Karachi 75500, Pakistan
9221-539-1561
tmumtaz@hsipl.com
www.hsipl.com
Autologous stem cells harvested from patient's blood using TriStem's patented retrodifferentiation process (creating stem cells from mature blood cells), then injected intravenously. The process is not yet proven, still in Phase 1 US trial, and is planned for aplastic anemia initially. No cost estimate available.
Biotechnology Center
Dr. R. Ravi Kumar
Chenai, India
Pierantonio Russo, MD (US Contact)
1-888-268-3470
Pierantonio.Russo@Temple.edu
Cardiovascular Cell Therapy
Autologous mesenchymal transplant of CD 34 and CD 133 cells into spinal cord through lumbar puncture. Claimed “60% improvement rate retained after one-year observation.” This and other claims for spinal cord injury found to be untrue. Dr. Russo now refuses to answer further questions.
BiomarkInternational (aka Advanced Cell Therapeutics)
US/CANADA/UK/Netherlands/South Africa/Seychelles
2002-2006
Laura Brown aka Jean Castle
Steven van Rooyen aka Sebastian Carlyle
Shut down as fraudulent by the FDA and equivalent agencies in all countries of prior operation. BioMark subcutaneously injected cells cultured in fetal bovine serum into the abdomens of more than 800 patients. Principals released on bail in South Africa 2006 and still successfully fighting extradition to US on 51 counts of fraud as of March 8, 2008.
Medra, Inc.
Malibu, CA (Performs surgical procedures in La Romana, Dominican Republic)
Dr. William C. Rader
www.medra.com
Intraveneous fetal cell injections generally using cells provided by EmCell (Kiev, Ukraine) or Kharkov Medical University's Institute for Problems of Cryobiology and Cryomedicine (Kharkov, Ukraine). Former psychiatrist, eating disorder clinician. Claims to cure virtually all diseases through single injection of human fetal cells.
Eden Laboratories Ltd. aka StarCapital Corp
Frederick House, 3rd Floor
Frederick Street
P.O. Box N-1985
Nassau, Bahamas
242-325-0120
www.edenlaboratories.net
Mitchell J. Ghen, D.O. has a long history (1993-present) of medical malpractice. His use of unverified human umbilical cord blood, with resultant ALS patient death and disrepair, has occurred in South Carolina, North Carolina, Florida, Georgia, Mexico, Belize and most recently as chief clinician of Eden Laboratories in Nassau, Bahamas.
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