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Stem Cell Therapy Certifications of Analysis

Certification of Analysis:

Below is information on the types of umbilical cord blood stem cells we use and example certifications of anyalysis for our umbilical cord blood derived stem cells. We use three types of umbilical cord blood stem cells in our treatment protocols -

CD34+hematopoietic stem cells:

Stem cells isolated from umbilical cord blood by immunomagnetic separation techniques. They are normally found as hematopoietic cells, endothelial progenitor cells, and endothelial cells of blood vessels.

The cells are non-adherent, translucent and round and are fully characterised as CD33+, CD38+ and CD34+ by flow cytometry.

  • Good morphology: non-adherent,translucent and round cells

  • Fully characterised with representative cell markers

  • Multipotent
  • Free of intellectual property hurdles 

Source: Human umbilical cord blood of donated umbilical cord obtained with informed consent and approved for stem cell derivation by the Institutional Ethics Committee (IEC) and ICSCRT (Institutional Committee for Stem Cell Research and Therapy)

Microbiological Tests: Maternal blood and cord blood tested negative for HIV I&II, HCV, CMV IgG/IgM, syphilis IgG/IgM antibodies and Hepatitis B surface antigen. Free of bacterial and fungal contamination.

Morphology: Non adherent translucent round cells

Representative Cell Surface Markers:

CD33+
CD38+
CD34+


Endotoxin Content: <10 EU/ml by LAL Test
Mycoplasma Testing: Negative
pH of the Medium: 7.4 ±0.2
Average Pre-Freeze Viability >90% (by FACS Analysis)
Average Purity >90% (by FACS Analysis)

 

Mesenchymal stem cells:

The stem cells are early passage multipotent progenitor cells derived from human cord blood that are capable of supporting hematopoiesis and differentiating into multiple lineages including: osteogenic, adipogenic, chondrogenic, neurogenic, myogenic, and cardiomyogenic.

The cells are adherent cells with spindle morphology, and are CD73+, CD105+ and CD45- by flow cytometry.

  • Spindle morphology consistent with bone marrow MSCs

  • Fully characterised with a panel of cell surface markers

  • Multipotent
  • Free of intellectual property hurdles 

Source: Human umbilical cord blood of donated umbilical cord obtained with informed consent and approved for stem cell derivation by the Institutional Ethics Committee (IEC) and ICSCRT (Institutional Committee for Stem Cell Research and Therapy)

Microbiological Tests: Maternal blood and cord blood tested negative for HIV I&II, HCV, CMV IgG/IgM, syphilis IgG/IgM antibodies and Hepatitis B surface antigen. Free of bacterial and fungal contamination.

Morphology: Adherent cells having spindle morphology

Representative Cell Surface Markers:

CD73+
CD105+
CD45-


Endotoxin Content: <10 EU/ml by LAL Test
Mycoplasma Testing: Negative
pH of the Medium: 7.4 ±0.2
Average Pre-Freeze Viability >90% (by FACS Analysis)
Average Purity >90% (by FACS Analysis)

 

 

COA CD34.png
 
 
Mesenchymal stem cell COA.pngmononuclear stem cell coa.png

 


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