The first US FDA approved cord blood product
Stem cells have great importance in regenerative medicine , they can be used to regenerate a lost tissue or to restore a hampered function of a tissue or to completely or partially replace a defective tissue, for example, stem cells are been successfully used in treatment of certain blood cancers and disorders.
Now HEMACORD is a first US FDA approved hematopoietic progenitor cells-cord (HPC-C) cell therapy product, which was approved by US FDA in the month of NOV 2011.
HEMACORD is used in treating disease of blood forming and blood cells (hematopoietic stem cell transplantation) , immune cells , to correct the auto immune diseases to replace over activated immune cells which are responsible for autoimmune diseases, as well as blood disorders like thalassemia major. Certain metabolic disorders like over activated enzyme system or completely absence of an enzyme in metabolic process too are treated by stem cell transplantation.
In 2009 US FDA had put two years time frame as phase in period for HPC-C product and had required their manufacturers to submit an ANDA or IND for such products after Oct. 20, 2011. And now HEMACORD is first US FDA approved hematopoietic progenitor cells-cord (HPC-C) cell therapy product.
HEMACORD is made up of stem cells (hematopoietic progenitor cells (HPCs) isolated from human cord blood.
There are three sources for basal stem cells 1. Bone marrow 2. Chord blood 3. The tissue it self , in case of blood cells it would be blood it self can be used as source of stem cells, first three sources are considered good sources as in last source the amount of tissue required to collect stem cells is very much higher.
The product is provided a boxed warning cautioning doctors about possibility of passing on host diseases, genetic disorders and anaphylactic and allergenic reactions to receiving individual, graft failure. This must be verified with the usefulness of the drug against the risks involved. Patients are also required to be monitor closely after HEMACORD administration.
New York Blood Center, Inc.from New York, USA is the manufacturers of HEMACORD.
Stem cells have great importance in regenerative medicine , they can be used to regenerate a lost tissue or to restore a hampered function of a tissue or to completely or partially replace a defective tissue, for example, stem cells are been successfully used in treatment of certain blood cancers and disorders.
Now HEMACORD is a first US FDA approved hematopoietic progenitor cells-cord (HPC-C) cell therapy product, which was approved by US FDA in the month of NOV 2011.
HEMACORD is used in treating disease of blood forming and blood cells (hematopoietic stem cell transplantation) , immune cells , to correct the auto immune diseases to replace over activated immune cells which are responsible for autoimmune diseases, as well as blood disorders like thalassemia major. Certain metabolic disorders like over activated enzyme system or completely absence of an enzyme in metabolic process too are treated by stem cell transplantation.
In 2009 US FDA had put two years time frame as phase in period for HPC-C product and had required their manufacturers to submit an ANDA or IND for such products after Oct. 20, 2011. And now HEMACORD is first US FDA approved hematopoietic progenitor cells-cord (HPC-C) cell therapy product.
HEMACORD is made up of stem cells (hematopoietic progenitor cells (HPCs) isolated from human cord blood.
There are three sources for basal stem cells 1. Bone marrow 2. Chord blood 3. The tissue it self , in case of blood cells it would be blood it self can be used as source of stem cells, first three sources are considered good sources as in last source the amount of tissue required to collect stem cells is very much higher.
The product is provided a boxed warning cautioning doctors about possibility of passing on host diseases, genetic disorders and anaphylactic and allergenic reactions to receiving individual, graft failure. This must be verified with the usefulness of the drug against the risks involved. Patients are also required to be monitor closely after HEMACORD administration.
New York Blood Center, Inc.from New York, USA is the manufacturers of HEMACORD.
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1 comments:
Dear writer of this blog
My name is Simon Egli and I'm a medical student from Basel, Switzerland. Currently, I'm working on my Masterthesis. The subject is to create a list of "Narrow Therapeutic Range Drugs". Please contact me by Mail, I'm very interested.
Yours faithfully
Simon Egli
simon.egli@stud.unibas.ch
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