Stem Cells International

Phases I–III Clinical Trials Using Adult Stem Cells


Publishing date
15 Oct 2010
Status
Published
Submission deadline
15 Apr 2010

1Stem Cell Biology Laboratory, Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA

2Center for Gene Therapy, Tulane University School of Medicine, New Orleans, LA 70808, USA

3UMR UPS/CNRS 5241 “Métabolisme, Plasticité et Mitochondrie,” University of Toulouse, INSERM, Toulouse, France

4Laboratory for cell therapy and tissue regeneration, Department of Physiology, School of Medicine, Pusan National University, Pusan, South Korea

5Department of Plastic Surgery, University of Tokyo Graduate School of Medicine, Tokyo, Japan


Phases I–III Clinical Trials Using Adult Stem Cells

Description

The field of regenerative medicine and tissue engineering has made significant advances in the past decade in large part due to improved methods of isolation and culture of stem cells from multiple tissues. Both academic and commercial biotechnology companies have collected substantial preclinical data characterizing stem cell products for autologous and allogeneic transplantation. These technologies are being translated to the bedside through partnerships between physicians, scientists, and manufacturing entities. These Phases I–III clinical trials have proceeded as a result of direct interaction between the clinician/investigators, sponsors, and the appropriate national and international regulatory authorities to ensure safety and efficacy of the stem cell product and protection of the human subjects.

In this special issue, we invite authors to submit original research articles as well as review articles, dealing with their experience and observations related to Phases I–III clinical trials involving stem cell products for human or veterinary therapy. We are particularly interested in articles that can share nonproprietary information relating to the type of preclinical data required to meet the requirements of the appropriate regulatory authority as well as information regarding the design, conduct, and outcomes of the clinical trial.

This issue is open to articles relating to adult stem cells as applied to any medical conditions. Both primary research articles and review/perspectives will be accepted for consideration; however, to be accepted, articles must be conducted in compliance with the Guidelines for Clinical Translation of Stem Cells as outlined by the International Society for Stem Cell Research (December 3, 2008 http://www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf) or an equivalent regulatory agency consistent with the International Conference on Harmonisation (ICH) / WHO Good Clinical Practice Guidelines. Topics may include, but are not limited to:

  • The use of human adult stem cells or adipose stromal vascular fraction cells for soft tissue cosmesis
  • The use of human adult stem cells for bone repair
  • The use of human adult stem cells for treatment of ischemic injury models (myocardial infarction, peripheral ischemia/claudication, stroke)
  • The use of human adult stem cells as anti-inflammatory or immunomodulatory agents
  • The use of adult stem cells for veterinary clinical applications
  • The use of adult stem cells for burn, skin, or wound repair

Before submission authors should carefully read over the journal's Author Guidelines, which are located at http://www.hindawi.com/journals/sci/guidelines/. Prospective authors should submit an electronic copy of their complete manuscript through the journal Manuscript Tracking System at http://mts.hindawi.com/ according to the following timetable:


Articles

  • Special Issue
  • - Volume 2010
  • - Article ID 604713
  • - Editorial

Phases I–III Clinical Trials Using Adult Stem Cells

Jeffrey M. Gimble | Bruce A. Bunnell | ... | Kotaro Yoshimura
  • Special Issue
  • - Volume 2010
  • - Article ID 193519
  • - Review Article

Translating Research into Clinical Scale Manufacturing of Mesenchymal Stromal Cells

Karen Bieback | Sven Kinzebach | Marianna Karagianni
  • Special Issue
  • - Volume 2010
  • - Article ID 582382
  • - Research Article

Cotransplantation of Adipose Tissue-Derived Insulin-Secreting Mesenchymal Stem Cells and Hematopoietic Stem Cells: A Novel Therapy for Insulin-Dependent Diabetes Mellitus

A. V. Vanikar | S. D. Dave | ... | H. L. Trivedi
  • Special Issue
  • - Volume 2010
  • - Article ID 519028
  • - Review Article

Mesenchymal Progenitor Cells and Their Orthopedic Applications: Forging a Path towards Clinical Trials

Deana S. Shenaq | Farbod Rastegar | ... | Tong-Chuan He
  • Special Issue
  • - Volume 2010
  • - Article ID 532704
  • - Research Article

Noncultured Autologous Adipose-Derived Stem Cells Therapy for Chronic Radiation Injury

Sadanori Akita | Kozo Akino | ... | Shunichi Yamashita
  • Special Issue
  • - Volume 2010
  • - Article ID 215625
  • - Review Article

Clinical Application of Human Mesenchymal Stromal Cells for Bone Tissue Engineering

Anindita Chatterjea | Gert Meijer | ... | Jan de Boer
  • Special Issue
  • - Volume 2010
  • - Article ID 579142
  • - Review Article

Phases I–III Clinical Trials Using Adult Stem Cells

Ricardo Sanz-Ruiz | Enrique Gutiérrez Ibañes | ... | Francisco Fernández-Avilés
  • Special Issue
  • - Volume 2010
  • - Article ID 503593
  • - Review Article

Culture and Use of Mesenchymal Stromal Cells in Phase I and II Clinical Trials

Bourin Philippe | Sensebé Luc | ... | Casteilla Louis
  • Special Issue
  • - Volume 2010
  • - Article ID 410170
  • - Review Article

Phases 1–3 Clinical Trials Using Adult Stem Cells in Osteonecrosis and Nonunion Fractures

Jean-Philippe Hauzeur | Valérie Gangji
  • Special Issue
  • - Volume 2010
  • - Article ID 259461
  • - Review Article

Stem Cell-Based Therapies for Liver Diseases: State of the Art and New Perspectives

Anna Chiara Piscaglia | Mariachiara Campanale | ... | Giovanni Gasbarrini
Stem Cells International
 Journal metrics
Acceptance rate45%
Submission to final decision76 days
Acceptance to publication35 days
CiteScore3.800
Impact Factor3.902
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