Cell Therapy News Volume 15.31 | Aug 11 2014

Gene Therapy Enhances Chemotherapy Tolerance and Efficacy in Glioblastoma Patients
Investigators conducted a prospective clinical trial to test whether gene therapy to confer O⁶-benzylguanine resistance in hematopoietic stem cells improves chemotherapy tolerance and outcome. [J Clin Invest]
Full Article | Press Release

Effects of Transendocardial CD34⁺ Cell Transplantation in Patients with Ischemic Cardiomyopathy
Scientists enrolled 33 patients with ischemic cardiomyopathy with New York Heart Association class III and left ventricular ejection fraction less than 40%. In Phase I, patients were treated with medical therapy for six months. Thereafter, all patients underwent transendocardial CD34⁺ cell transplantation. [Circ Cardiovasc Interv] Abstract

Supramolecular Hydrogels for Long-Term Bioengineered Stem Cell Therapy
In situ supramolecularly assembled and modularly modified hydrogels for long-term engineered mesenchymal stem cell therapy are reported using cucurbit[6]uril-conjugated (CB[6]) hyaluronic acid (HA), diaminohexane conjugated HA, and drug-conjugated CB[6]. [Adv Healthc Mater] Abstract

Regeneration of Uterine Horns in Rats Using Collagen Scaffolds Loaded with Human Embryonic Stem Cell-Derived Endometrium-Like Cells
Investigators established the uterine full-thickness-injury rat models to test cell function in vivo. Human embryonic stem cell-derived cells were dropped onto collagen scaffolds and transplanted into the animal model. [Tissue Eng Part A] Abstract

Intra-Arterial Immunoselected CD34⁺ Stem Cells for Acute Ischemic Stroke
Researchers performed a prospective, nonrandomized, open-label, Phase I study of autologous, immunoselected CD34⁺ stem/progenitor cell therapy in patients presenting within seven days of onset with severe anterior circulation ischemic stroke. [Stem Cells Transl Med] Abstract | Press Release

Human Umbilical Cord Mesenchymal Stem Cells and Derived Hepatocyte-Like Cells Exhibit Similar Therapeutic Effects on an Acute Liver Failure Mouse Model
Investigators used a D-galactosamine plus lipopolysaccharide-induced acute liver failure mouse model, which caused death of about 50% of the mice with necrosis of more than 50% hepatocytes, to compare the therapeutic effects of human umbilical cord mesenchymal stem cells before and after induction of differentiation into hepatocyte. [PLoS One] Full Article

Haploidentical Hematopoietic Stem Cell Transplantation with Umbilical Cord-Derived Multipotent Mesenchymal Cell Infusion for the Treatment of High-Risk Acute Leukemia in Children
Twenty-five children with high-risk acute leukemia have received haploidentical hematopoietic stem cell transplantation with co-transfusion of umbilical cord multipotent mesenchymal cells. [Leuk Lymphoma] Abstract

A Systematic Review of Preclinical Studies on the Therapeutic Potential of Mesenchymal Stromal Cell-Derived Microvesicles
A systematic review of controlled interventional animal studies was performed to identify models of organ injury where clinical translation of mesenchymal stromal cell-derived microvesicle therapy appears most promising as regenerative therapy. [Stem Cell Rev] Abstract

Visit our reviews page to see a complete list of reviews in the cell, gene and immunotherapy research field.

Quark Pharmaceuticals Reports Favorable Results from Phase II Clinical Trial Evaluating Investigational siRNA QPI-1002
Quark Pharmaceuticals, Inc. reported data from a randomized, double-blinded, placebo-controlled multicenter Phase II clinical trial of QPI-1002, a synthetic chemically modified siRNA acting to reduce p53 RNA and protein levels, for the prophylaxis of delayed graft function in deceased donor kidney transplant patients. [Quark Pharmaceuticals, Inc.] Press Release

Dissections Banned in Indian Universities
A long campaign to persuade Indian authorities to bar dissections in university classes has achieved a major victory. The University Grants Commission, a governmental body that sets standards for university education in India, has banned the dissection of animals in zoology and life science university courses. [ScienceInsider] Editorial

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Cesca Therapeutics and Fortis Healthcare Announce Master Collaboration Agreement
Cesca Therapeutics and Fortis Healthcare Limited announced a master collaboration agreement that extends their important existing relationship. The agreement affirms Cesca’s cellular therapy and cord blood bank at the Fortis Hospital Memorial Research Institute, renews the cord blood banking collaboration and launches the stem cell therapy services for hematological diseases across the Fortis network. [Cesca Therapeutics Inc.] Press Release

Cynata Contracts University of Wisconsin – Madison to Advance Cymerus™ Stem Cell Product Development
Cynata Therapeutics Ltd. announced that it has signed an agreement with the University of Wisconsin – Madison to develop a novel approach for preserving cell therapy products to enhance their shelf life and convenience. [Cynata Therapeutics Ltd.] Press Release

FDA Modifies Tekmira’s TKM-Ebola Clinical Hold to Partial Hold
Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced that the U.S. Food & Drug Administration (FDA) has verbally confirmed they have modified the full clinical hold placed on the TKM-Ebola Investigational New Drug Application to a partial clinical hold. [Tekmira Pharmaceuticals Corporation] Press Release

Celladon Announces Initiation of Clinical Trial to Investigate MYDICAR in Patients with Heart Failure and a Left Ventricular Assist Device (LVAD)
Celladon Corporation announced that the first patient has been dosed in a clinical trial titled “Investigation of the Safety and Feasibility of AAV1/SERCA2a Gene Transfer in Patients with Heart Failure and a LVAD,” which is designed to assess the potential utility of MYDICAR in advanced heart failure patients whose hearts are being supported by LVADs. [Celladon Corporation] Press Release

AMNIOX^® Medical Announces Initiation of Prospective, Randomized, Controlled Clinical Study of Chronic Wounds
Amniox Medical, Inc., a developer and marketer of restorative therapies processed from amniotic membrane and umbilical cord, announced the initiation of a randomized, controlled clinical trial of its proprietary product in patients with chronic wounds. [Amniox Medical, Inc. (Business Wire)] Press Release

Alnylam Receives Orphan Drug Designations in the European Union for ALN-AT3, an RNAi Therapeutic in Development for the Treatment of Hemophilia
Alnylam Pharmaceuticals, Inc. announced that the European Medicines Agency Committee for Orphan Medicinal Products has granted Orphan Drug Designations for ALN-AT3 as an orphan medicinal product for the treatment of hemophilia A and hemophilia B. [Alnylam Pharmaceuticals, Inc.] Press Release

TapImmune’s New Clinical Trial in Advanced Stage Ovarian Cancer Expands the Use of Folate Receptor Alpha Peptide Antigens
TapImmune Inc. announced that a new grant funded Phase I clinical study on the safety and Immunogenicity of folate receptor alpha peptide vaccine in patients with advanced stage epithelial ovarian cancer has started at the Mayo Clinic, Rochester. [TapImmune Inc. (Business Wire)] Press Release

Cedars-Sinai Immunotherapy Expert Honored for Work in Kidney Transplantation
Ashley Anh Vo, PharmD, administrative director of the Transplant Immunotherapy Program at the Comprehensive Transplant Center at Cedars-Sinai, has been named the 2014 Clinician of Distinction by the American Society of Transplantation for her work in developing anti-rejection drug protocols for patients. [Cedars-Sinai Medical Center (EurekAlert!)] Press Release

In Vitro Companion Diagnostic Devices; Guidance for Industry and FDA Staff; Availability (FR Doc. No: 2014-18538)

Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability (FR Doc. No: 2014-18169)

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.

Senior PhD Scientist – Oncology Cell Therapeutics (Novartis Institutes for BioMedical Research)

Postdoctoral Research Fellow – In-Situ Gene Therapy (Fred Hutchinson Cancer Research Center)

Technical Account Manager (GlobalStem)

Research Scientist – iPSC Biology and Genome Editing (Stem Cell Theranostics)

Research Assistant – iPSC Biology and Genome Editing (Stem Cell Theranostics)

Postdoctoral Researcher – Generation of Myocardium In Situ (Van Andel Research Institute)

Postdoctoral Fellow – AAV Vectors for Gene Therapy of Neurological and Other Disorders (University of Massachusetts Medical School)

Postdoctoral Scientist – Immune Focused In Vitro Analytics (Celentyx Ltd.)

Scientist – Pluripotent Stem Cell Media Development, High Throughput Screening (STEMCELL Technologies Inc.)

Scientist – Cell Culture Support Products (STEMCELL Technologies Inc.)

Scientist – Liver Cell Biology (STEMCELL Technologies Inc.)

Scientist – Immunology/Cell Separation (STEMCELL Technologies Inc.)

Research Associate – Cell Separation (STEMCELL Technologies Inc.)

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