Regenerative Therapy

U.S. Food and Drug Administration (FDA) approved Fibrocell’s Biologics License Application for its lead product, laVív® (azficel-T).  June 2011.
laVív is a process that extracts and multiplies fibroblasts from a person’s own skin. LAVIV is then injected into the patient to improve the appearance of smile lines. In normal skin, fibroblasts are responsible for producing collagen.
Fibrocell Science Inc. 
Exton, PA, US
http://www.fibrocellscience.com/

First Patients Enrolled in Two Clinical Trials Using Embryonic Stem Cells to Treat Stargardt’s Disease and Dry Age-Related Macular Degeneration (SMD). Phase 1/2 clinical trials using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patients were enrolled at the Jules Stein Eye Institute at the University of California, Los Angeles (UCLA).
Source: Advanced Cell Technology, Inc
http://www.advancedcell.com/

April 2011: Pluristem announced positive results in clinical studies, reducing amputation rate in patients with critical limb ischemia.
Source: http://www.pluristem.com/index.php?option=com_content&view=article&id=165:-april-6&catid=4&Itemid=104
Three dimentional growth of placenta derived mesenchymal stromal cells; phase I study sponsored by Pluristem Therapeutics Inc.
Scientific articles on the technology are published in peer reviewed journals by doctors affiliated with the company.
http://www.pluristem.com/plx.asp
Clinical study: Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)
http://clinicaltrials.gov/ct2/show/NCT00951210?term=pluristem&rank=1 Phase I completed.
Israel

Advanced Cell Technology (ACT) AMD stem cell clinical phase

Patient Enrollment for Phase II Clinical Trial in Inflammatory Bowel Disease
Treatment using MultiStem®, Athersys’ allogeneic cell therapy product for the treatment of ulcerative colitis (UC). 
The Phase II study is a randomized, double-blind, placebo-controlled, multi-center study designed to investigate the safety and efficacy of MultiStem in subjects with moderate to severe UC. The trial will be conducted at multiple clinical sites in North America and Europe, and is expected to include up to approximately 126 patients. Individuals …

Clinical trial: Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit.
A Phase 1  Study of an Autologous Neo-Urinary Conduit in Subjects Requiring Incontinent Urinary Diversion Following Radical Cystectomy.  Neo-Urinary Conduit(NUC), is made in the laboratory from a combination of a patient’s own cells and other materials can be used to form a conduit to safely allow urine flow from the kidneys to outside the body after radical cystectomy in patients with bladder cancer.
Technology developed by Tengion Inc.  http://www.tengion.com
Study …

New clinical trial approval:  (February 2011)
The Drugs Controller General of India (DCGI) has given permission to a Bangalore-based company, Stempeutics Research, for carrying out Phase-II clinical trials to find out the efficacy of stem cell therapy. The trial will begin in April in Bangalore, Delhi and Kochi in association with hospitals.
Clinical indications for the trial are: chronic diabetes, alcoholic liver cirrhosis and chronic obstructive pulmonary disease (COPD). Stem cells will be obtained from either embryonic stem cells, …

Case report on treatment of spinal injury with non related (allogeneic) stem cells. Reported in International Archives of Medicine on December 2010. 
Ichim et al. International Archives of Medicine 2010, 3:30
http://www.intarchmed.com/content/pdf/1755-7682-3-30.pdf
Cell combination for treatment composed of CD34+ cord blood derived stem cells and mesenchymal progenitor cells derived from cord tissue. Technology developed by Medistem Inc. San Diego, USA.  http://www.medisteminc.com/

A phase I/II trial, prospective, open-label study designed to determine the safety and tolerability of stem cells product, following sub-retinal transplantation to patients with advanced Stargardt’s Macular Dystrophy. A total of twelve patients will be enrolled in the study at multiple clinical sites in the US. Stem cells for the treatment are produced from embryonic stem cells induced to differentiate into  retinal pigment epithelium.
Technology was developed by Advanced Cell Technology, Inc. and the company announced the approval …

Phase I/II Clincial Trial:  Evaluating safety and efficacy of sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease (CKD) patients using EPODURE Biopump
About the Technology

   Biopump relative to a toothpick

CKD patients with insufficient endogenous EPO production are treated with a steady source of erythropoietin (EPO) produced and delivered by tiny autologous dermal tissue samples implanted subcutaneously.  The protein is released continuously for months, without significant fluctuations in secretion levels, thereby enabling the stabilization of the …