Navigation Links
Stemedica Requests Pre-IND Meeting With FDA
Date:8/21/2009

Stemedica Cell Technologies, Inc. USA, a leader in adult stem cell research and manufacturing, has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") to discuss a proposed IND to use Stemedica's proprietary line of allogeneic mesenchymal bone marrow cells (adult human) as a treatment for ischemic stroke.

San Diego, CA (PRWEB) August 21, 2009 -- Stemedica Cell Technologies, Inc. USA, a leader in adult stem cell research and manufacturing, has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") to discuss a proposed IND to use Stemedica's proprietary line of allogeneic mesenchymal bone marrow cells (adult human) as a treatment for ischemic stroke.

Stroke is a leading cause of adult impairment, with 20% of stroke survivors requiring institutional care after 3 months and up to 30% severely and permanently disabled. The only approved treatments of acute ischemic stroke involves restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics (tPA) is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy.

"Following a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy," said Nikolai Tankovich, MD, PhD, President & Chief Medical Officer. "Treatment with allogeneic mesenchymal bone marrow cells may offer new hope to patients with chronic neurological or age-related, neurodegenerative diseases."

Allogeneic mesenchymal bone marrow cells are obtained from donors by extracting bone marrow and are expanded at Stemedica's cGMP compliant facility, which is licensed by the California Department of Public Health, Food and Drug Branch. "Stemedica's facility will manufacture clinical grade stem cells as it prepares for FDA approval of an IND to begin clinical trials," said Maynard Howe, PhD, Vice Chairman and CEO of Stemedica.

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 Stemedica Cell Technologies, Inc. contact Dave McGuigan at dmcguigan (at) stemedica.com.

# # #

Read the full story at http://www.prweb.com/releases/Stemedica-Stroke/PRE-IND-FDA/prweb2776804.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related biology technology :

1. Stemedica Announces the Appointment of Dr. Michael Bayer as Director, Medical Services
2. CIRM Completes Briefing Visit to Stemedica Cell Technologies
3. Renowned Stem Cell Researcher Files Study Results With Stemedica
4. Stemedica Signs Scientific Advisory Board Agreement with Leading Pediatric Burn & Wound Care Researcher
5. Sinovac Requests Extension for Annual Shareholders Meeting
6. CryoCor Requests International Trade Commission Investigation Into CryoCath for Patent Infringement
7. deCODE Requests Hearing With Nasdaq Following Receipt of Staff Determination Letter
8. Biotechnology Value Fund, L.P. Requests Avigen Board to Provide Critical Information to Stockholders
9. Xmark Requests That Icagen Oust Its CEO and Pursue Strategic Alternatives, and Calls on Board Members to Resign
10. The West Michigan Science & Technology Initiative is Named Statewide Reviewer for Life Science Funding Requests Through New Program
11. Arius completes Pre-IND Meeting with FDA for Lead CD44 Cancer Stem Cell Program
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Stemedica Requests Pre-IND Meeting With FDA
(Date:2/5/2016)... On Thursday, February 11, 2-1-1 San ... health and disaster services, and the Community Information ... care coordination and service delivery for the community to ... to better connect service providers to the information they ... Diego has handled more than 2.5 million ...
(Date:2/4/2016)... ... February 04, 2016 , ... Morf Media Inc ... an interactive FDA compliance training course, Writing Effective SOPs ... accredited interactive course on Morf Playbook—now conveniently available on smartphones and PCs--provides step ...
(Date:2/4/2016)... ... February 04, 2016 , ... Shimadzu ... quad LC-MS, host live demos and poster sessions, and present on the analysis ... conference takes place March 6 to 10 at the Georgia World Congress Center ...
(Date:2/4/2016)... JUNCTION, N.J. , Feb. 4, 2016 /PRNewswire/ ... care immunotherapy leader commercializing its flagship CytoSorb® blood ... cardiac surgery patients around the world, announced that ... will present at the Source Capital Group,s 2016 ... and update on the company.  ...
Breaking Biology Technology:
(Date:2/5/2016)... DUBLIN , Feb. 5, 2016 /PRNewswire/ ... the addition of the "Global Facial ... offering. --> http://www.researchandmarkets.com/research/5kvw8m/global_facial ) has ... Facial Recognition Market 2016-2020" report to ... Markets ( http://www.researchandmarkets.com/research/5kvw8m/global_facial ) has announced the ...
(Date:2/3/2016)... February 3, 2016 --> ... research report "Automated Fingerprint Identification System Market by Component ... Application (Banking & Finance, Government, Healthcare, and Transportation) and ... the market is expected to be worth USD 8.49 ... between 2015 and 2020. The transformation and technology evolution ...
(Date:2/2/2016)... Feb. 2, 2016  BioMEMS devices deployed ... focused on medical screening and diagnostic applications, ... Wearable devices that facilitate and assure continuous ... movement are being bolstered through new opportunities ... signal acquisition coupled with wireless connectivity and ...
Breaking Biology News(10 mins):