Navigation Links
Arteriocyte Receives FDA Approval to Initiate Cellular Therapy Trial for Treatment of Thermal Burn Wounds in Wounded Warriors
Date:1/31/2013

CLEVELAND, Jan. 31, 2013 /PRNewswire/ -- Arteriocyte, a leading biotechnology company with offices in Cleveland, Ohio and Hopkinton, Massachusetts announced today approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial using its Magellan® System technology in the treatment of thermal burn wounds. The FDA Investigational Device Exemption (IDE-15140) allows Arteriocyte and its clinical partners to initiate evaluation of autologous platelet gel (APG) (using the Magellan® Autologous Platelet Separator technology) as an adjunctive therapy for autologous skin grafting in patients with thermal injuries. This treatment has been developed in partnership with the United States Telemedicine and Advanced Technology Research Center (TATRC), and the University of Utah Health Science Center and Intermountain Burn Center. Arteriocyte is initiating a series of investigations employing Arteriocyte's Magellan® Autologous Platelet Rich Plasma and Bone Marrow Derived Stem Cell Based Therapies for Burn Wounds as part of Arteriocyte's Cellular Therapies for Battlefield Wounds Program.

The Magellan® System is an FDA 510(k) cleared medical device for the rapid production of Platelet Rich Plasma from blood and bone marrow that can be applied to a surgical site as surgeons deem necessary for their clinical use requirements.  Magellan® MAR01a technology enables the rapid Operating Room based "closed system" concentration of aspirated bone marrow, yielding an injectable tissue rich in platelets, hematopoietic stem cells and mesenchymal stem cells in as little as fifteen minutes. The self-contained Magellan® Unit provides critical ease-of-use and operator-independent consistency necessary for deployment in military medical operations. Arteriocyte has partnered with the U.S Military to develop Magellan® MAR01a in clinical use across three trauma platforms: Extremity Trauma, Burn Wounds and Infection Prevention.

The current clinical protocol will evaluate the Magellan® Autologous Platelet Gel as an adjunctive therapy to improving skin graft acceptance and integration in thermally injured patients. Autologous Platelet Gel is used to improve adherence of the autologous skin graft, while providing beneficial growth factors and antimicrobial protection ensuring graft survival.  

"We're thrilled to see that industry continues to pursue the development of point-of-care cellular therapies to advance military medicine," said COL Lee Cancio , MD, a surgeon at the U. S. Army Institute of Surgical Research Burn Center at the San Antonio Military Medical Center. "Programs like this are examples of efforts to improve stabilization, retention and readiness for thousands of our Wounded Warriors."  

Enrollment into the Burn clinical trial is anticipated to begin in early 2013 and will be conducted at The University of Utah's Health Science Center and Burn Center, led by Drs. Amit Patel , MD and Amalia Cochran , MD.

Arteriocyte CEO Don Brown said, "We are and will continue to be committed to improving care delivery for our men and women in uniform and to do our best to help those that serve and protect our country. The extraordinary vision and commitment of our partners at TATRC and SAMMC to develop and deliver the best care possible for our combat wounded Soldiers is to be lauded."

About Arteriocyte   
Arteriocyte, a leading clinical stage biotechnology company, is dedicated in developing novel stem cell products and medical devices to help patients heal faster. Arteriocyte leverages its expertise in stem cell and tissue engineering in order to develop a broad portfolio of cell based therapeutics to improve patient outcomes. In October of 2007, Arteriocyte partnered with DW Healthcare Partners and Comerica to create Arteriocyte Medical Systems Inc., in order to commercialize and distribute novel medical devices and point of care surgical solutions to address serious unmet medical needs in cardiac, orthopedic and vascular surgeries. Arteriocyte Medical Systems manufactures and distributes the Magellan® Autologous Platelet Separator System


'/>"/>
SOURCE Arteriocyte
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. PAREXEL Chief Operating Officer Dr. Mark A. Goldberg Receives Special Recognition Award
2. Leica Biosystems Receives FDA Approval for the Fully Automated Bond Oracle™ HER2 IHC System on the Leica BOND-MAX
3. Nephros Receives 510(k) Clearance for Hemodiafiltration System
4. ProUroCare Medical Receives FDA Clearance for ProUroScan Elasticity Imaging System
5. BONESUPPORT Receives Red Herring 2012 Top 100 Europe Award
6. Diabecline Antibiotic Receives Edison Award for Best New Pharmaceutical Product
7. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
8. Alexza Receives Complete Response Letter for Adasuve™ NDA
9. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
10. Marshall Edwards Receives $4 Million Subscription From Novogen In Rights Offering
11. New Chronic Wound Treatment Device Receives Award from Veterans Healthcare Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... -- Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided an ... Puerto Rico , where the company ... Following a comprehensive onsite assessment, ... damage, temporary loss of power and minimal water damage ... operations have resumed, and the company expects to return ...
(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 ...
(Date:10/5/2017)...  In response to the nationwide opioid epidemic, ... (AAOMS) released prescribing recommendations that urge ibuprofen – ... a first-line therapy to manage a patient,s acute ... Recognizing the value and importance of the ... Acute and Postoperative Pain Management" stresses that practitioners ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Journey: From the Mountains to the Mission Field”: the story of a missionary couple ... From the Mountains to the Mission Field” is the creation of published author, Carole ... and currently teaches a class of ladies at her church, which she has taught ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... IsoComforter, Inc. ... products, announced today the introduction of an innovative new design of the shoulder pad. ... so you get maximum comfort while controlling your pain while using cold therapy. By ...
(Date:10/12/2017)... Rockville, Maryland (PRWEB) , ... October 12, 2017 ... ... a magnetic drug delivery system that we intend to develop to enable prevention ... regimens can lead to severe hearing loss, especially in pediatric patients. For cisplatin, ...
(Date:10/12/2017)... D.C. (PRWEB) , ... October 12, 2017 , ... Leading ... their peers in Washington, D.C., for the 49th Congress of the International Society ... ., Vice President of the Center for Cancer and Blood Disorders at ...
Breaking Medicine News(10 mins):