Clinical trials for Umbilical Cord MSC for progressive MS

Discuss stem cells, adult and embryonic, and their therapeutic potential for MS here.

Clinical trials for Umbilical Cord MSC for progressive MS

Postby Liberation » Thu Feb 23, 2012 2:33 am

Purpose
Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis.

Current therapies provide only modest control of progressive Multiple Sclerosis and Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with progressive MS and NMO.


Condition Intervention Phase
Progressive Multiple Sclerosis
Neuromyelitis Optica.
Biological: human umbilical cord mesenchymal stem cells
Phase I
Phase II



Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica


Resource links provided by NLM:


MedlinePlus related topics: Multiple Sclerosis
U.S. FDA Resources



Further study details as provided by Shenzhen Beike Bio-Technology Co., Ltd.:


Primary Outcome Measures:
•Score of Expanded Disability Status Scale (EDSS) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]


Secondary Outcome Measures:
•Visual Evoked Potential (VEP) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]

•Brainstem Auditory Evoked Potential (BAEP) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]

•Somatosensory Evoked Potential(SEP) [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]

•Brain Magnetic Resonance Imaging (MRI) Scan [ Time Frame: 1 year after treatment ] [ Designated as safety issue: No ]


Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

http://clinicaltrials.gov/ct2/show/NCT01364246
Last edited by Liberation on Thu Feb 23, 2012 6:18 am, edited 1 time in total.
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Re: Safety and Efficacy of Umbilical Cord MSC for MS

Postby Liberation » Thu Feb 23, 2012 2:38 am

Could it be that USC is a better source of MSC than bone marrow or fat? Here is a part of an article:

"How many stem cells are provided in a normal treatment period?
Patients typically receive five to eight stem cell packets during a typical one-month treatment cycle with each packet containing a minimum of 20 million stem cells (this is a minimum and the actual number in the packet may be larger up to 200 million). Beike’s partner centers can also collect and prepare autologous bone marrow-derived stem cells—your own body’s adult stem cells. Many centers around the world only use bone marrow-derived stem cells for their treatments. Because of the limit in the amount of stem cells that can be cultured from the bone marrow the use of autologous bone marrow-derived stem cells in our protocols is only offered as a supplment to the base umbilical cord or cord blood-derived stem cell treatment."...

"Treatment of leukemia and lymphona by use of adult stem cells from the bone marrow since the 1970s has shown no manifestation of increased tumor formation.
Beike stem cells are not allowed to multiply over two cycles during the culturing and amplification process. A stem cell that is allowed to multiply in a culture dish for a lengthy period of time has the potential to become cancerous."...


http://www.circleofmoms.com/umbilical-c ... ers-632760
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Re: Clinical trials for Umbilical Cord MSC for progressive M

Postby Liberation » Thu Feb 23, 2012 7:14 am

New Research Demonstrates Safety of Cord-blood-derived Stem Cell Treatments
Beike Biotechnology and Medistem, Inc. Report on 114 Patients Treated With Novel Cord Blood Stem Cell Protocol; New Approach Opens Door to Expanded Uses of Cord Blood Stem Cells

SHENZHEN, China, Sept. 2 /PRNewswire-Asia/ -- In a new peer-reviewed article published by the Journal of Translational Medicine, scientists from Beike Biotechnology ( http://www.beikebiotech.com/ ), China's leading stem cell research and regenerative medicine company, and Medistem, Inc. (Pink Sheets: MEDS; http://www.medisteminc.com ), reported positive safety data in 114 patients who were treated by doctors at Nanshan Affiliated Hospital of Guangdong Medical College (Shenzhen Nanshan Hospital) in Shenzhen using Beike's proprietary cord blood stem cell transplantation protocol.

The peer-reviewed paper is available at http://bit.ly/cBNBYt .

The report aims to serve as an "expanded Phase I" study, with efficacy data to be published in a subsequent paper. It describes biochemical, hematological, immunological, and general safety profiles of patients with neurological diseases who were observed from between one month to four years after treatment. No serious treatment-associated adverse effects were observed. Dr. Wanzhang Yang, who led the study at Nanshan Affiliated Hospital of Guangdong Medical College commented, "This important study, which is the largest of its kind, demonstrates the safety and efficacy of using cord-blood-derived stem cells to treat a variety of neurological conditions. However, it also suggests cord-blood-derived stem cells are a safe and viable treatment option for a much broader range of diseases and conditions than previously thought."

Because the protocol developed by Beike allows the use of cord blood stem cells without immune suppression, it can be made available to a wide patient population. Until now, patients receiving cord blood transplants to fight hematopoietic diseases were immune-suppressed in order to prevent a potentially devastating condition known as "graft versus host." This new research challenges the necessity of that practice.

Medistem CEO Thomas Ichim stated, "It is an honor to collaborate with Beike on this seminal publication. The fact that Beike has been able to demonstrate safety of transplant by manipulating an established stem cell source is a substantial advancement for the field. These new findings could open up the use of cord blood for non-hematological diseases, something that to date has not been performed on a wide-spread basis."

Dr. Travis Ye, Beike Biotech's CEO, commented, "This groundbreaking research is consistent with the safety record we have compiled after providing stem cells for the treatment of more than 8,000 patients. It is our hope that studies and peer-reviewed articles such as this one will help strengthen our ties to the western medical and scientific research community by demonstrating that Beike's stem cell protocols are both effective and safe."

The study was conducted by a team of researchers from Beike, Medistem, Nanshan Affiliated Hospital of Guangdong Medical College, the University of Western Ontario (Canada), and University of California, San Diego.

About Beike Biotech:

Shenzhen Beike Biotechnology Co., Ltd. is China's leading biotechnology company focusing on the production of adult stem cells for use in medical therapies. Headquartered in Shenzhen (near Hong Kong) with a flagship regenerative medicine facility at the China Medical City in Jiangsu province, Beike produces a full line of stem cell products derived from umbilical cord, cord blood and autologous bone marrow. Currently, the stem cell therapies supported by Beike treat a variety of different medical conditions: ataxia, brain injury, cerebral palsy, lower limb ischemia, lupus, multiple sclerosis, muscular dystrophy, spinal cord injury, and optic nerve pathologies.

About Medistem, Inc.:

Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia. A publication describing the support for use of ERC for this condition may be found at http://bit.ly/bQ80t0 .

Cautionary Statement:

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

For more information, please contact:

Shenzhen Beike Biotechnology Company, Ltd.
T. Gutmann
Shenzhen Hi-Tech Industrial Park
Tel: +86-755-8630-9200
Email: info@beikebiotech.comThis e-mail address is being protected from spambots. You need JavaScript enabled to view it
Web: http://www.beikebiotech.com

SOURCE Shenzhen Beike Biotechnology Company, Ltd.
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