BioInformant

Your Global Leader in Stem Cell Market Research

MENUMENU
  • Blog
    • Interviews
  • News
  • Stem Cells
    • iPS Cells
    • MSCs
    • HSCs
    • Adipose SCs
    • Neural Stem Cells
  • Exosomes
  • CAR-T
  • Cord Blood
  • Shop
    • Products
    • Submit PR
    • Advertise
  • About
    • Testimonials
    • Story
    • Guarantee
    • Contact
  • Home
  • Blog
    • Stem Cells
      • HSCs
      • iPS Cells
      • MSCs
      • Neural Stem Cells
      • Adipose SCs
    • Exosomes
    • Cell Therapy
      • CAR-T
    • Cord Blood
    • Stem Cell News
    • Interviews
  • COVID-19
  • Shop
  • Submit PR
  • Company
    • Advertise
    • Testimonials
    • Story
    • Job Posts
    • Guarantee
    • Privacy Policy
    • Contact
Home » FDA Grants IND Approval to Stemedica for a Traumatic Brain Injury Phase IIa Clinical Trial
FDA Grants IND Approval to Stemedica for a Traumatic Brain Injury Phase IIa Clinical Trial - Depositphotos_9073986_m-2015.jpg

FDA Grants IND Approval to Stemedica for a Traumatic Brain Injury Phase IIa Clinical Trial

May 18, 2016 By Cade Hildreth (CEO) Leave a Comment

Clinical trial to study the effects of Stemedica’s proprietary mesenchymal stem cells in patients with traumatic brain injury.   

Discover class-defining bioproduction tools.

SAN DIEGO, California;  May 18, 2016 — Stemedica Cell Technologies, Inc. (Stemedica) received an FDA investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its ischemic tolerant, adult allogeneic mesenchymal stem-cells (itMSC) to treat subjects with traumatic brain injury (TBI).  The study is sponsored by Stemedica with ProMedica Health Care Systems of Toledo, Ohio serving as both the trial site and a co-financial supporter of the trial.  The clinical trial is titled “A Phase IIa, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells to Subjects with Moderate Traumatic Brain Injury.”

“Stemedica has achieved another milestone by expanding its clinical program in the United States to six major medical indications under IND approval including ischemic stroke, acute myocardial infarction, chronic heart failure, photoaging skin, Alzheimer’s disease and now traumatic brain injury,” said Lev Verkh, Ph.D., Stemedica’s Chief Regulatory & Clinical Development Officer. “We are investigating several medical indications we believe are best suited for our ischemic tolerant mesenchymal stem cells while collecting important safety and preliminary efficacy data on the effects of our stem cells. Our goal is to provide medical options to patients with our product.”

bitbio

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’s itMSCs are manufactured at its government licensed, cGMP (current good manufacturing practices) facility in San Diego, California.

According to the Centers for Disease Control and Prevention (CDC), causes of TBI include falls, motor vehicle crashes, colliding with a person or object and assault.  Symptoms of TBI include balance problems; double or blurry vision; sensitivity to light or noise; concentration or memory problems; and mood changes such as irritability, sadness, nervousness and anxiety.  In 2010, 2.5 million emergency room visits, hospitalizations or deaths were related to TBI alone, total costs of which exceed $82 billion annually, including medical and work loss costs.

Pluristyx

“Stemedica is pleased to be advancing this clinical trial in the investigation of traumatic brain injury,” says Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica.  “As the number one cause of death and long-term disability in young people, the prolonged problems it is creating for our military veterans and the pronounced impact it is having on our sports heroes is substantial.  Any role our stem cell product can play in aiding those suffering from TBI is worth researching.  Along with our partner ProMedica, we are committed to determining the potential role stem cells can play in the treatment of traumatic brain injury.”

The Phase IIa clinical trial will enroll approximately twenty-four (24) patients as part of its study population.  Contact research@ProMedica.org for TBI clinical trial information.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures 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 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 stem 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.

iPSC-derived cardiomyocte therapy

 

Contacts
Stemedica Cell Technologies, Inc.

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


Want to be better informed than your competition? Get future stem cell industry updates.

 

About BioInformant

BioInformant is the first and only market research firm to specialize exclusively in the stem cell industry. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Medical Ethics, Vogue Magazine, and more. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in stem cell industry data.

Rate this post

Filed Under: MSCs, Stem Cells Tagged With: regenerative medicine, stem cells, Stemedica, traumatic brain injury

Related

About Cade Hildreth (CEO)

Cade Hildreth is the Founder of BioInformant.com, the world's largest publisher of stem cell industry news. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, Xconomy, and Vogue Magazine. 

Tell Us What You Think! Cancel reply

Nanocellect

Marathon Products

Let’s Get Social

  • Facebook
  • Twitter
  • LinkedIn
  • Pinterest
  • Instagram
Menu
  • Blog
  • Stem Cell News
    • Press Releases
  • Stem Cells
    • HSCs
    • iPS Cells
    • MSCs
    • Neural Stem Cells
    • Adipose SCs
  • Exosomes
  • Cell Therapy
    • CAR-T
  • Cord Blood
  • Interviews

Cart

Featured Posts

Cord Blood Market Segmentation

Cord Blood Market Segmentation – Biobanking, HSCT, Cellular Therapy, Genetic Manipulation, & Research Tools

CAR-T Companies

CAR-T Cell Companies Proliferate: List of CAR-T Companies Worldwide

Who discovered stem cells?

Who Discovered Stem Cells? The Answers Revealed

My Tweets

BioInformant's World-Class Clients

  • Submit Press Release
  • Advertise
  • Privacy and Terms

Copyright © 2022 · BIOINFORMANT, Your Global Leader in Stem Cell Market Research

| Email: Info@BioInformant.com | Phone: 703-859-7617 |

800 Corporate Drive, Suite 301, Stafford, VA 22554, United States

Disclaimer: All statements made on this website are NOT expressed as medical claims or advice. They are not intended to diagnose, treat, cure or prevent any disease or condition. If you have a health condition or concern, consult your physician or health care provider.