Navigation Links
Stemedica Requests Pre-IND Meeting With FDA

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. ( 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)

    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:
(Date:11/24/2015)... LAUSANNE and BERN, Switzerland ... SA, the ARTORG Center for Biomedical Engineering Research of ... and the Division of Endocrinology, Diabetes and Clinical Nutrition ... announce the start of an exclusive collaboration to develop ... control algorithm for the personalised delivery of insulin for ...
(Date:11/24/2015)... , November 24, 2015 st  Scientific ... North America (RSNA) taking place in Chicago ... Booth 1122, Hall A. --> st  Scientific Assembly and ... (RSNA) taking place in Chicago ... Hall A. --> Molecular Dynamics will present its revolutionary ...
(Date:11/24/2015)... , November 24, 2015 The uptake of ... will be a key driver of market growth to 2021, ... recently approved and pipeline premium products for Type 1 Diabetes Mellitus (T1DM), ... says GBI Research . --> The uptake ... (T1DM), will be a key driver of market growth to 2021, ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... ... Students and parents have something to be thankful for this Thanksgiving week ... California Casualty is proud to support the contest designed to utilize peer-to-peer ... the number one killer of young drivers. , Almost 1,000 entries of original ...
(Date:11/24/2015)... ... , ... New patients who wish to seek treatment for missing teeth can ... her Mississauga, ON practice. Dr. Williams has been providing dental service for over 34 ... Missing teeth can lead to a variety of complications if they are not replaced ...
(Date:11/24/2015)... ... 2015 , ... Catalent Pharma Solutions, the leading global provider ... global clinical supply services, today announced that Dr. Christine Milligan, Global Director, Strategic ... to be held at the InterContinental Seoul COEX Hotel, Seoul, Republic of Korea, ...
(Date:11/24/2015)... Boston, MA (PRWEB) , ... November 24, 2015 ... ... today announced that the organization will waive paid entry and parking fees at ... in Hingham, and Monument Mountain in Great Barrington in support of REI’s Black ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... United States to support their local poison centers through donations on Tuesday, Dec. ... calls it “a day that inspires people to collaborate in improving their ...
Breaking Medicine News(10 mins):