Regenerative Therapy

Regenerative medicine company Histogenics Corporation, announced today the presentation of intermediate term data supporting the clinical efficacy of the Company’s NeoCart Autologous Cartilage Tissue Implant (ACTI) for periods of up to five years with no evidence of severe treatment-related adverse events in patients with grade III chondral injury to the femur (cartilage damage in the knee).
NeoCart® is an implant grown ex vivo (outside the body) from the patient’s own cartilage cells.
NeoCart recently entered a Phase …

Report on intermediate results of clinical study:
The publication showed that a single non-surgical injection of Mesoblast’s allogeneic mesenchymal progenitor cells (MPCs) into damaged intervertebral discs resulted in significant regeneration of disc anatomy, increase in proteoglycan content, and increase in disc height, for at least six months.
Published in:
Journal of Neurosurgery, Posted online on March 9, 2012
Entitled “Immunoselected STRO-3+mesenchymal precursor cells and restoration of the extracellular matrix of degenerate intervertebral discs”, can be viewed at:
http://thejns.org/doi/full/10.3171/2012.1.SPINE11852
Mesoblast, Australia

 Paper title:
“Cellular Therapy With Ixmyelocel-T to Treat Critical Limb Ischemia: The Randomized, Double-blind, Placebo-controlled RESTORE-CLI Trial”
Richard J Powell et al. Molecular Therapy ( April 2012)
From the abstract:
“Ixmyelocel-T is a patient-specific, expanded, multicellular therapy evaluated in patients with lower extremity critical limb ischemia (CLI) with no options for revascularization. This randomized, double-blind, placebo-controlled, phase 2 trial (RESTORE-CLI) compared the efficacy and safety of intramuscular injections of ixmyelocel-T with placebo. 
“ Ixmyelocel-T treatment was well tolerated and may offer …

Title:
Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients.
Glass JD, et al Stem Cells. 2012 Mar 13. [Epub ahead of print]
Abstract:
http://www.ncbi.nlm.nih.gov/pubmed/22415942.1
Phase I safety trial of intraspinal injections of fetal-derived neural stems cells in patients with Amyotrophic Lateral Sclerosis (ALS).
Emory University School of Medicine, Atlanta, GA USA

A phase I/II clinical study using modified  non related stem cells for treating stable ischemic stroke.
Recruiting patients April 2011
http://clinicaltrials.gov/ct2/show/NCT01287936?term=Stanford%2C+SanBio&rank=1
Performed in Stanford University School of Medicine, CA US.
Sponsored by SanBio Inc. http://www.san-bio.com/
March 2012
SanBio Announces Enrollment of First Cohort of Patients in Its Clinical Trial of Stem Cell Therapy for Chronic Stroke
http://www.san-bio.com/news/documents/SanBio_First_Cohort_2012.03.20.pdf

Phase III clinical study, testing safety and efficacy of targeted intramyocardial delivery of autologous CD34+ cells from mobilized peripheral blood, for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.
The trial will enroll 450 patients in 50 clinical sites in the United States,  randomized to three arms: treatment with their own autologous CD34+ stem cells, treatment with placebo (control), or unblinded standard of care.
ClinicalTrials website:  http://clinicaltrials.gov/ct2/show/NCT01508910?term=baxter+cardiac&rank=6
Responsible Party: Baxter …

Physicians at ARMC  completed a clinical trial involving autologous stem cell therapy that showed success in the treatment of chronic wounds and pressure ulcers. Six of nine patients in the trial had wounds that closed completely – a rate of 67 percent.
Arrowhead Regional Medical Center, California, USA
https://www.arrowheadmedcenter.org/default.aspx?id=11#feb14

“Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived multipotent stem cells.”
Zhao y. et al 2012 BMC Med. 10;10(1):3
“Stem Cell Educator therapy can markedly improve C-peptide levels, reduce the median glycated hemoglobin A1C (HbA1C) values, and decrease the median daily dose of insulin in patients with some residual beta cell function (n = 6) and patients with no residual pancreatic islet beta cell function (n = 6). Treatment …

BrainStorm Announces Clinical Data Supporting Safety and Efficacy of NurOwn™ Based on Initial ALS Patient Results
The ALS Phase I/II human clinical trial is being performed at Hadassah Medical Center in Israel in collaboration with BrainStorm and is utilizing BrainStorm’s NurOwn™ technology for growing and modifying autologous adult human stem cells to treat ALS, often referred to as Lou Gehrig’s Disease. The study is headed by Prof. Karussis, M.D., Ph.D
http://www.brainstorm-cell.com/Index.asp?ArticleID=260&CategoryID=76&Page=1

New clinical study to treat hearing loss by cord blood stem cells has been approved by the FDA:
“Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children”
Acquired sensorineural hearing loss i children will be treated with autologous cord blood cells. The primary objective of this study is to determine the safety of autologous hUCB infusion in children with acquired hearing loss. The secondary objective is to determine if functional, physiologic and anatomic outcomes …