Navigation Links
FDA Grants IND Approval for Phase IIa Clinical Trial Using Stemedica's itMSC Therapy to Treat Alzheimer's Disease
Date:6/9/2015

SAN DIEGO and EPALINGES, Switzerland, June 9, 2015 /PRNewswire/ -- Stemedica Cell Technologies, Inc. received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with mild to moderate dementia due to Alzheimer's disease (AD), the sixth leading cause of death in the United States.   The study is sponsored by Stemedica International, S.A. and will start at the University of California, San Diego (UCSD) under Principle Investigator Douglas Galasko, M.D. and expand to other sites.  Stemedica International will provide management and financial support for this clinical trial.  The clinical trial is titled "A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer's Disease."

"This study was approved based on the excellent safety profile of Stemedica's cGMP-manufactured, hypoxically-grown stem cells and on solid pre-clinical data obtained by Stemedica International in cooperation with the École Polytechnique Fédérale de Lausanne of Switzerland and with a grant from the Swiss government," said Lev Verkh, Ph.D. Stemedica's Chief Regulatory & Clinical Development Officer. He continued, "We are very proud of Stemedica's clinical program under U.S. INDs for several indications including ischemic stroke, acute myocardial infarction, chronic heart failure, cutaneous photoaging and Alzheimer's disease.  At the study's conclusion we will understand if our approach is efficacious versus placebo in subjects with Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints."

Stemedica's bone marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing. Stemedica International's AD stem cell therapies feature itMSCs, neural stem cells (NSCs) and stem cell factors, which are described in Stemedica International's U.S. Patent application #20140286910.

Promising results were achieved during a three-year, intensive, pre-clinical research project supported by a grant from the Swiss Commission for Technology and Innovation (CTI). The research was conducted at the Laboratoire d'Optique Biomedicale headed by Professor Theo Lasser at École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland.

Stemedica International's pre-clinical research was led by Chief Scientist Tristan Bolmont, Ph.D. To evaluate the impact of an intravenous delivery of human mesenchymal stem cells on amyloid pathology, the well-established APPPS1 transgenic mouse model of Alzheimer's disease was used.  Intravenous delivery of itMSC safely reduced cerebral Abeta pathology in APPPS1 animals analyzed one week after the last injection. Both aged and young APPPS1 mice exhibited significantly decreased Abeta amyloidosis following the itMSC treatments. Concomitantly, microglial activation was diminished in aged and young itMSC-treated APPPS1 mice. No increase of vascular amyloid or manifestation of microhemorrhages was observed following the repeated intravenous itMSC delivery. Biodistribution analysis revealed that intravenously delivered itMSC migrate to the brain and could be detected in this organ with the highest value at one hour post-delivery, decreasing after one day and subsequently dropping below detection level at one week after the injection.

According to Alzheimer's Disease International, nearly 44 million people have Alzheimer's or a related dementia. Alzheimer's and dementia are most common in Western Europe followed closely by North America. The global cost of Alzheimer's and dementia is estimated to be $605 billion USD, which is close to 1% of the world's gross domestic product.

"We are very excited to take this next step in developing a treatment for this devastating disease," says Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica Cell Technologies and Executive Chairman for Stemedica International. "Our upcoming Phase IIa clinical trial will enable us to make progress towards determining if our stem cell treatment may be able to halt or slow down the progression of Alzheimer's disease and other forms of dementia."

About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors.  The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer's disease.  Stemedica's products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials.  Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory institutions.  The company is headquartered in San Diego, California and can be found online at www.stemedica.com.

About Stemedica International S.A.
Founded in Epalinges, Switzerland, in 2008, Stemedica International S.A. is a global biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer's disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has an exclusive license to manufacture and distribute the parent company's allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer's disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies' cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit www.stemedica-intl.com.

Key Words
Stemedica, Stemedica International, biotechnology, bio-therapeutics, biologics, drug delivery, stem cells, adult stem cells, Alzheimer's, dementia, clinical trial, cGMP

Contacts

Stemedica Cell Technologies, Inc.
Dave McGuigan
VP, Marketing & Business Development 
dmcguigan@stemedica.com 
+1 858-658-0910 x7203

Stemedica international, S.A.
David Cheatham, MBA
Business Manager
dcheatham@stemedica.com 
+41 (0)21 651 9050

Logo - http://photos.prnewswire.com/prnh/20150323/183977LOGO

 


'/>"/>
SOURCE Stemedica Cell Technologies, Inc.
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Grants Soligenix "Fast Track" Designation for SGX942 for the Treatment of Oral Mucositis in Patients with Head and Neck Cancer
2. Agnitio Grants 10,000 New Licenses Globally this Financial Year
3. Avanir Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
4. FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt
5. FDA Grants Orphan Drug Status To Eisais Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma
6. The Kenneth Rainin Foundation Continues its Commitment to Ending Inflammatory Bowel Disease, Awarding $1.5 Million in Research Grants
7. European Union Grants a Good Manufacturing Practice Certificate to Nelson Laboratories
8. FDA Grants Orphan Drug Designation to Omeros OMS824 for Huntingtons Disease
9. FDA Grants Lillys Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer
10. Life Technologies Awards Digital PCR Innovation Grants to Five Research Labs
11. Philanthropic Grants, Product Launches, Promising Partnerships, and Customer Satisfaction Rankings - Research Report on CVS Caremark, Walgreens, McKesson, AmerisourceBergen, and Cardinal Health
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/11/2019)... , ... September 11, 2019 , ... ... headquartered in Irving, Texas, that exclusively serves premier oral and maxillofacial surgeons – ... an oral and maxillofacial surgery practice with three locations in the Atlanta area. ...
(Date:9/11/2019)... ... September 11, 2019 , ... Genedata, the leading ... globally operating Finnish pharmaceutical company, has licensed Genedata Biologics® to support their R&D ... , “As part of our strategy to expand our biopharmaceutical R&D operations, ...
(Date:9/11/2019)... ... September 10, 2019 , ... Women’s Excellence is pleased ... recognition of Breast Cancer Awareness Month. In additional to standard weekly appointments, Women's ... 26, 2019 , Women’s Excellence has earned ACR accreditation for mammography services. The ...
Breaking Medicine Technology:
(Date:9/8/2019)... , ... September 06, 2019 , ... ... a historic milestone as its fall 2019 enrollment has reached an all-time high ... students) in master’s and doctoral level candidates, totaling 374 students. The total does ...
(Date:9/8/2019)... ... September 06, 2019 , ... The Plantrician Project is pleased to introduce ... Nutrition Healthcare Conference, where close to 1000 medical professionals from 25 countries, will ... to the use of whole food, plant-based nutrition in clinical practice. ...
(Date:9/8/2019)... ... September 07, 2019 , ... Messaging Architects, an eMazzanti Technologies ... recent successful GroupWise to Office 365 email migration on the Messaging Architects website. ... healthcare organization. , The informative article discusses the tight timeline faced by the ...
(Date:9/4/2019)... ... September 04, 2019 , ... Strategic Radiology has engaged Dan ... practices, representing 28 group practices and more than 1,100 radiologists. , Schriger is ... health care. From 2013 until recently, Dan was director of sales and business ...
(Date:9/4/2019)... ... September 04, 2019 , ... R3 Stem ... 18-19th, 2019. The nation's leading hands-on regenerative training course includes two days of ... is $1000 off, and each attendee also receives a free stem cell procedure ...
Breaking Medicine News(10 mins):