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 …

Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived multipotent stem cells
Yong Zhao, Zhaoshun Jiang, Tingbao Zhao, Mingliang Ye, Chengjin Hu, Zhaohui Yin, Heng Li, Ye Zhang, Yalin Diao, Yunxiang Li, Yingjian Chen, Xiaoming Sun, Mary Beth Fisk, Randal Skidgel, Mark Holterman, Bellur Prabhakar and Theodore Mazzon
BMC Medicine 2012, 10:3  http://www.biomedcentral.com/1741-7015/10/3/abstract
“A procedure for Stem Cell Educator therapy in which a patient’s blood is circulated through a closed-loop system that separate lymphocytes from the whole blood and briefly co-cultures them with adherent CB-SCs before returning them …

Two clinical studies testing autologous cord blood infusion for treatment of children with cerebral palsy, now recruiting patients (November 2011):
1. “Safety and Effectiveness of Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children”
http://www.clinicaltrials.gov/ct2/show/NCT01072370?term=cerebral+palsy&rank=1

Medical College of Georgia
 

Augusta, Georgia, United States

2. “A Randomized Study of Autologous Umbilical Cord Blood Reinfusion in Children With Cerebral Palsy”
http://www.clinicaltrials.gov/ct2/show/NCT01147653?term=cerebral+palsy&rank=5

Duke University Medical Center
 

Durham, North Carolina, United States

November 14 2011 Geron said it would stop enrolling patients in its study of a stem cell-based treatment for spinal cord injury, after treating four patients.
Sep tember 2010 Phase I trial to evaluate GRNOPC1 in patients with  grade A subacute thoracic spinal cord injuries. The primary study endpoint is safety, but additional secondary endpoints will assess efficacy of the treatment in terms of improved neuromuscular control or sensation in the trunk or lower extremities.
GRNOPC1 is Geron’s cell product …

Pilot Study Evaluating the Safety and Efficacy of Transplantation of UCB-derived ex Vivo Expanded Stem and Progenitor Cells (NiCord), in Combination With a Second, Unmanipulated CBU in Patients With Hematological Malignancies (ALL, AML, Myelodysplastic Syndrome (MDS), Non-Hodgkin’s lymphoma or Hodgkin’s disease).
Study coducted at: United States, North Carolina Duke University Medical Center
 Presently recruiting patients 10.2011
Clinica Trials website: 
http://clinicaltrials.gov/ct2/show/NCT01221857?term=gamida+cell&rank=1
Gamida Cell Ltd. Israel:
http://www.gamida-cell.com/products.asp?ID=4&t=NiCord™

Results reported on a prospective non-randomized clinical trial to study the safety and efficacy of endobronchial infusion of adipose derived stem cells in patients with idiopathic pulmonary fibrosis. Twelve patients with IPF of moderate disease severity were enrolled. Preliminary results showed a statistically significant improvement in parameters related to quality of life 6 and 12 months after the first infusion, as well as pulmonary function and exercise capacity tests 12 months post infusion.” Stem cells …

Advanced Cell Technology of Worcester, Mass., was granted by the FDA permission  to test its “MA09-hRPE” human embryonic stem cells on human patients afflicted with Stargardt’s Macular Dystrophy (a rare blindness syndrome),  citing successful animal experiments.
http://www.advancedcell.com/
Study in the US started in July at the Jules Stein Eye Institute at the University of California, Los Angeles, and at Oregon Health and Sciences University, Portland, Oregon.
Studies in Europe started in September 2011 at the  Moorfields Eye Hospital in …

The most significant case for disease eradication after adoptive cell therapy is the TIL treatment.
A recent review summarizes the clinical data: Nat Rev Clin Oncol. 2011 Aug 2. Cell transfer immunotherapy for metastatic solid cancer-what clinicians need to know. Rosenberg SA; Medscape.
“Cancer immunotherapy using the adoptive transfer of autologous tumor-infiltrating lymphocytes results in objective cancer regression in 49-72% of patients with metastatic melanoma. In a pilot trial combining cell transfer with a maximum lymphodepleting regimen, …

Two publications on novel approach for treatment of chronic lymphoid leukemia by autologous engineered T lymphocytes – clinical data for one (1) or three (2) patients.
Published in: 
1. New England Journal of Medicine:
“Chimeric Antigen Receptor–Modified T Cells in Chronic Lymphoid Leukemia”
David L. Porter, M.D., Bruce L. Levine, Ph.D., Michael Kalos, Ph.D., Adam Bagg, M.D., and Carl H. June, M.D.
August 10, 2011
http://www.nejm.org/doi/full/10.1056/NEJMoa1103849?query=featured_home
2. Sci Transl Med 2011:
Vol. 3, Issue 95, p. 95
“T Cells with Chimeric Antigen Receptors Have Potent Antitumor …

Report on clinical results of treatment of venous leg ulcers.
“Positive Results for Phase IIb Trial of Unique Cell-Based Therapy in Venous Leg Ulcers”
The product tested is  allogeneic living cell suspension that are sprayed sequentially on the wound bed at the time of treatment: a fibrinogen solution and a cell preparation containing a mixture of growth arrested, living, allogeneic epidermal keratinocytes and dermal fibroblasts.
Healthpoint Biosciences
http://www.healthpointbio.com/