Navigation Links
Stemedica Completes Meeting with the FDA
Date:10/15/2009

Stemedica Cell Technologies, Inc. announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigative New Drug) to evaluate the safety and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke. Based on a meeting October 13, 2009 with the FDA, Stemedica is planning to file an IND application in the first quarter of 2010.

San Diego, CA (PRWEB) October 15, 2009 -- Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigative New Drug) to evaluate the safety and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke. Based on a meeting October 13, 2009 with the FDA, Stemedica is planning to file an IND application in the first quarter of 2010.

The proposed 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 a clinical diagnosis of chronic neurological or age-related neurodegenerative disease with significant functional or neurologic impairment 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. The proposed trial will take place at medical centers within the United States.

"This is an important milestone for Stemedica," said Nikolai Tankovich, MD, PhD, Stemedica's President and Chief Medical Officer. "In addition to the official licensing of our manufacturing facility in San Diego, California, we can now establish our own clinical trial pathways for our various products. Stemedica's goal is to receive regulatory approvals for the clinical application of all of its products."

"With constructive feedback from the FDA we can work on fine-tuning the proposed treatment protocol and advance our proposed clinical trial to targeted medical facilities for full consideration," said Michael Levy, MD, PhD. Dr. Levy is the Chief of Pediatric Neurosurgery, Rady Children's Hospital of San Diego, Professor of Surgery, UCSD School of Medicine and the Principal Investigator for the proposed clinical trial.

Stemedica was granted its license by the State of California's Department of Public Health, Food and Drug Branch to manufacture stem cells for clinical trials in July, 2009. The Drug Manufacturing License grants Stemedica the right to manufacture clinical-grade (for human use) drug or biologic products and recognizes Stemedica as being compliant with California law and the applicable provisions of 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 Stemedica Cell Technologies, Inc. contact Dave McGuigan at dmcguigan at stemedica.com.

###

Read the full story at http://www.prweb.com/releases/stemedica-stem-cell/ischemic-stroke-FDA/prweb3053264.htm.


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

Related biology technology :

1. United States Patent and Trademark Office Publishes Stemedica's Patent Application for the Treatment of Diabetic Retinopathy
2. The Jordanian Stem Cell Company Acquires Stem Cell Technology From Stemedica International S.A. - First Clinical Trail Anticipated To Begin Early 2010
3. Stemedica Achieves Major Milestone - Company Receives License to Manufacture Clinical Grade Stem Cells
4. Stemedica Selected By World Stem Cell Summit To Present Scientific Discoveries
5. Stemedica Requests Pre-IND Meeting With FDA
6. Stemedica Signs Scientific Advisory Board Agreement with Leading Pediatric Burn & Wound Care Researcher
7. Renowned Stem Cell Researcher Files Study Results With Stemedica
8. CIRM Completes Briefing Visit to Stemedica Cell Technologies
9. Stemedica Announces the Appointment of Dr. Michael Bayer as Director, Medical Services
10. Ipsen and Debiopharm Group Announce That Decapeptyl(R)(triptorelin embonate) 6-month Successfully Completes the European Decentralised Procedure for the Treatment of Locally Advanced or Metastatic Prostate Cancer
11. Jennerex Completes Over-Subscribed Series C Financing for Aggregate Gross Proceeds of Over $5.5 Million
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Stemedica Completes Meeting with the FDA
(Date:5/26/2016)... 2016 Despite the volatility that continues ... space. Today,s pre-market research on ActiveWallSt.com directs the investor community,s ... RDUS ), Cerus Corp. (NASDAQ: CERS ... Five Prime Therapeutics Inc. (NASDAQ: FPRX ). Register ... http://www.activewallst.com/ On Wednesday, shares in ...
(Date:5/25/2016)... ... May 25, 2016 , ... Thailand’s ... at BIO 2016 in San Francisco. Located at booth number 7301, representatives from ... answer questions and discuss the Thai biotechnology and life sciences sector. , ...
(Date:5/25/2016)... ... May 25, 2016 , ... WEDI, the nation’s leading authority on ... that Charles W. Stellar has been named by the WEDI Board of Directors as ... As an executive leader with more than 35 years of experience in healthcare, association ...
(Date:5/24/2016)... CA (PRWEB) , ... May 24, 2016 , ... Last ... planning for corporate executives and entrepreneurs, held The Future of San Diego Life Science ... the San Diego life science community attended the event with speakers Dr. Rich Heyman, ...
Breaking Biology Technology:
(Date:4/14/2016)... BioCatch ™, the global ... the appointment of Eyal Goldwerger as CEO. ... Goldwerger,s leadership appointment comes at a time of significant ... of its platform at several of the world,s largest ... unique cognitive and physiological factors, is a winner of ...
(Date:3/23/2016)... 2016 Einzigartige ... und Stimmerkennung mit Passwörtern     ... MESG ), ein führender Anbieter digitaler Kommunikationsdienste, ... SpeechPro zusammenarbeitet, um erstmals dessen Biometrietechnologie einzusetzen. ... Möglichkeit angeboten, im Rahmen mobiler Apps neben ...
(Date:3/17/2016)... 17, 2016 ABI Research, the leader ... global biometrics market will reach more than $30 ... from 2015. Consumer electronics, particularly smartphones, continue to ... anticipated to reach two billion shipments by 2021 ... Pavlakis , Research Analyst at ABI Research. "Surveillance ...
Breaking Biology News(10 mins):