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Quality Standards

Step 1: Donor Consent

Tissue procurement center is responsible for obtaining or verifying legally valid consents of all donors of tissues/placenta and completing medical & social histories of all such donors.

Step 2: Donor Serology and Microbiology Testing

Prior to eligibility determination, Human Cell and Tissue Products (HCT/Ps) is evaluated according to the following serology test requirements: 

a) Human Immunodeficiency Virus (HIV) Type 1 antibody (HIVI Ab). 

b) Human Immunodeficiency Virus (HIV) Type 2 antibody (HIV2 Ab). 

c) Human T-Lymphotrophic Virus (HTLV) Type 1 antibody (HTLV I). 

d) Human T-Lymphotrophic Virus (HTLV) Type II antibody (HTLV II).  

e) Hepatitis C Antibody (HCV). 

f) Hepatitis B surface antigen (HBs Ag). 

g) Hepatitis B total core antibody (HBcAb). 

h) Rapid Plasma Reagin (RPR) for Syphilis or Serologic Test for Syphilis (STS). 

i) Human immunodeficiency Virus (HIV) Type 1 / Hepatitis C Virus Nucleic Acid Test (NAT) Duplex (HIV-1/HCV NAT by TMA).

Infectious disease testing is performed only by laboratories maintaining current registration status with concerned medical authorities.  All serological testing is performed in accordance with the accepted standards. Additional testing to confirm or supplement serologic test results may be performed at the discretion of the Medical Director.

Recovery Cultures shall be interpreted as follows:If all culture results are reported as "No Growth", culture results are interpreted as acceptable.

Step 3: Amniotic membrane preparation

a) Collect recently Caesarian delivered placenta (after all above mentioned tests have been performed confirming safety of usage).

b) Subsequently, amniotic membrane is peeled off from the placenta & 2 cm squares are cut off from the membrane & weighted under sterile conditions.

Step 4: Amniotic Membrane Storage

a) Each 2cm square is placed in a 60 cc vial.

b) The vial contains preservative capable of maintaining the vital functions of the amniotic membrane for periods up to 90 days.

c) The vial is then sealed & placed in the refrigerator at 5º C.

 Ready for implantation! 

 
© 2008 Dr. Omar Gonzalez, Stem Cell Treatment, Degenerative diseases treatment, Cells derived from placenta, Diabetes treatment stem cell, stem cell therapy, stem cell transplantation, Stem cell transplantation therapy, Hepatitis C treatment Stem cell, Hepatitis C treatment stem cell therapy