Navigation Links
FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
Date:4/20/2010

Stemedica Cell Technologies, Inc. (Stemedica) announced that the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug (IND) for a clinical trial for ischemic stroke using Stemedica's high potency proprietary allogeneic stem cells (adult human).

San Diego, California (PRWEB) April 20, 2010 -- Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that the U.S. Food and Drug Administration (FDA) approved an Investigational New Drug (IND) for a clinical trial for ischemic stroke using Stemedica's high potency proprietary allogeneic stem cells (adult human).

“The FDA acceptance of our IND application and the clinical protocol for usage of allogeneic mesenchymal bone marrow-derived stem cells in subjects with ischemic stroke is an important milestone for Stemedica in its development program,” said Nikolai Tankovich, MD, PhD, Stemedica’s President and Chief Medical Officer. “Currently, patients suffering from ischemic stroke have very limited treatment options. We hope that bringing this novel option to the medical community will help to alleviate the burden of a serious and disabling disease and will be valuable for both patients and their family members.”

The IND application approval allows Stemedica to initiate a planned clinical trial at medical centers within the United States. The clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with significant functional or neurologic impairment related to the ischemic stroke that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living.

“This approval, along with the licensing of our cGMP manufacturing facility, are two important breakthroughs in our company’s evolution,” said Maynard Howe, PhD, Stemedica’s Vice Chairman & CEO. “It is a testament to the professionalism and focused persistence of our team.”

Stemedica is licensed by the State of California’s Department of Public Health, Food and Drug Branch to manufacture stem cells, drugs and biologic products for human clinical trials. The Company is compliant with both California law and the Code of Federal Regulations.

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan(at)stemedica(dot)com.

###

Read the full story at http://www.prweb.com/releases/stemedica-IND/Stroke-StemCell/prweb3902694.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related medicine news :

1. New York State Office of Mental Health Approves New High Performance Polycarbonate Sheet for Use in All Facilities
2. House of Representatives Approves Health-Care Reform Bill
3. Congress Approves Bill Curbing Internet Tobacco Sales in Victory for Kids and Taxpayers
4. New Jersey Approves Initiative to Expand the Number of Wound Care Certified Professionals
5. Golden Meditech Shareholders Approves of Name Change
6. The American Association of Anatomists approves guidelines for body donation programs
7. Kaiser Permanente Approves $170 Million in Community Benefit Grants in 2009
8. State Approves Certificate of Need for New PeaceHealth San Juan Island Hospital
9. A Christmas Gift for Eric: Senate Approves Health Care Bill in Historic Christmas Eve Vote
10. Medizone International, Inc. Approves Repurchase of Global Marketing Rights
11. FDA Approves First Additive Solution for Platelet Storage Up to 5 Days
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves Stemedica IND for Ischemic Stroke Clinical Trial
(Date:9/21/2017)... (PRWEB) , ... September 21, 2017 , ... ... with offices serving communities in northern Alabama and Georgia, is embarking on an ... prevention by utilizing modern early detection methods. , US Breast Cancer statistics ...
(Date:9/20/2017)... ... September 20, 2017 , ... Collins Concrete Coatings announced that ... rely on safety and cleanliness. This unique flooring system uses silver ion technology ... for centuries for its antimicrobial properties. Unlike antibiotics, which kill specific microorganisms, silver ...
(Date:9/20/2017)... ... September 20, 2017 , ... ... company specializing in medical device compliance and commercialization, has just released a ... activities. , FDA is more adamant than ever about medical device, pharmaceutical, ...
(Date:9/20/2017)... Cleveland, Ohio (PRWEB) , ... September 20, 2017 ... ... commitment to customer service and innovation, the company recently unveiled a redesigned website. ... to further enrich the work of building owners, architects, contractors and other industry ...
(Date:9/20/2017)... ... September 20, 2017 , ... The Honey Pot Company is ... goal is to ignite conversation via social media and word-of-mouth regarding vaginal health, ... declared September “Humans with Vaginas” month, releasing a video celebrating the power of ...
Breaking Medicine News(10 mins):
(Date:9/5/2017)... -- Just 18 months after its February 2016 launch, market ... appointment of three new senior people to its rapidly ... and James Wright bring decades of ... Tammy Wynne joins as Director, Value ... has over ten years, experience in global market access ...
(Date:8/31/2017)... PM360,s annual Innovations Issue, published in ... innovations happening across the industry. Established six years ago, ... providing a comprehensive look at the newest and most ... innovative companies, startups, divisions, products, services, and strategies from ... "Everyone in this industry wants to do better—in all ...
(Date:8/25/2017)... -- Innovation Zed ( www.innovationzed.com ), an Irish medtech company, today announced that ... and Bassetlaw, England . The ... as part of a national NHS Test Bed programme exploring new models ... Innovation Zed ... InsulCheck Connect, a snap-on accessory for disposable insulin pen users, automatically collects ...
Breaking Medicine Technology: