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

SAN DIEGO, Aug. 21 /PRNewswire/ -- 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.

    Media contact:
    Dave McGuigan
    Stemedica Cell Technologies, Inc.
    +1 858 658 0910


'/>"/>
SOURCE Stemedica Cell Technologies, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Velcura Therapeutics, Inc. Reports Positive Pre-IND Meeting With FDA and Plans Early Clinical Trials for New Drug to Treat Multiple Myeloma Bone Disease
2. HUYA Bioscience Intl Announces First Pre-IND Outcome for a Development Stage Compound Sourced From China - HBI-8000, Promising New Cancer Compound
3. HUYA Bioscience Intl Announces Pre-IND Outcome for HBI-3000 - Promising Anti-Arrhythmia Compound Sourced From China
4. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
5. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
6. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
7. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
8. Biopure Reports on Meeting with the FDA
9. Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
10. Pivotal Ustekinumab (CNTO 1275) Phase 3 Data to Debut at World Congress of Dermatology Meeting
11. Positive Results for NKTR-118 (oral PEG-naloxol) Presented at American Academy of Pain Management Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... , Oct. 12, 2017 West ... in innovative solutions for injectable drug administration, today announced ... the market opens on Thursday, October 26, 2017, and ... results and business expectations at 9:00 a.m. Eastern Time. ... or 253-336-8738 (International). The conference ID is 94093362. ...
(Date:10/11/2017)... 11, 2017  True Health, a leader in ... effort during National Breast Cancer Awareness month to ... Research recently ... that more than 10 million American women are ... BRCA1 or BRCA2 and have not had testing. These ...
(Date:10/10/2017)... 2017   West Pharmaceutical Services, Inc. (NYSE: ... drug administration, today shared the results of a study ... the intradermal administration of polio vaccines. The study results ... May 2017 by Dr. Ondrej Mach , Clinical ... Organization (WHO), and recently published in the journal ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at ... of the most popular and least understood books in the Holy Scriptures, Revelation. The ... that have baffled scholars for centuries. Many have tossed it off as mere rubbish, ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... healthcare compliance program management, will showcase a range of technology and learning solutions ... Living (NCAL) Convention and Expo to be held October 14–18, 2017 at the ...
(Date:10/12/2017)... , ... October 12, 2017 , ... The American College ... to Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in ... , In honor of Morris F. Collen, a pioneer in the field of medical ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at ... D.C., for the 49th Congress of the International Society of Paediatric Oncology ... the Center for Cancer and Blood Disorders at Children’s National, and Stephen ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... the latest in wound care advancements to physician colleagues, skilled nursing facility medical ... titled, "Navigating the Treacherous Waters of Wound Care." , "At many of these ...
Breaking Medicine News(10 mins):