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Measuring Stem Cell Health and Quality:

Tools for Cellular Therapy and

Regenerative Medicine

 

 

CTSummary

 

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HemoGenix® is the only company that has made the need for ensuring high quality stem cell therapy products a Number 1 Priority. In many cases, the presence of stem cells in a product is assumed, but rarely, if ever, measured to ensure stem cell health. HemoGenix® has developed tests specifically for this need.

 

Cellular therapy and regenerative medicine are multi-billion dollar industries that produce and use biological products for clinical treatments. The treatment of patients with stem cells, immunotherapies and other biologics to alleviate and/or cure diseases, requires products with the highest possible quality and potency.

 

Many of the tests developed by HemoGenix® are available with luminescence, fluorescence or absorbance readouts, thereby allowing investigators to use any plate reader available. However, some tests are only available with a luminescence endpoint, because these tests require the highest degree of accuracy and precision.

 

Tools for Hematopoietic Stem Cell Health and Therapy

The following reagents and assays can be used with fresh or cryopreserved umbilical cord blood and cord tissue, bone marrow and normal and mobilized peripheral blood. These sources can be total nucleated cell (TNC) fractions, mononuclear cell (MNC) fractions or highly purified CD34+, CD133+ or other stem cell fractions.

 

  • HemoGro™ Serum-Free Medium.
  • CellExpand™: HemoGro™ medium containing growth factor cocktails to stimulate stem cells, lymphoid cells or hematopoietic progenitor cells in suspension culture.
  • ColonyGro™: Traditional methylcellulose colony-forming unit (CFU) reagents (100mL for 44 samples).
  • CAMEO™-4: Miniaturized, methylcellulose colony-forming unit (CFU) assay kits (50 samples, including 50 culture plates).
  • HALO® PCA: A 5-day, colony-forming unit (CFU) - equivalent, complete ATP bioluminescence progenitor cell assays without methylcellulose.
  • HemoFLUOR™ PCA: Same as HALO®-96 PCAEQ, but with a fluorescence readout.
  • HemoLIGHT™ PCA: Same as HemoFLUOR™-96 PCAEQ, but with an absorbance/colorimetric readout
  • STEMpredict: A 3-day complete assay to predict stem cell functionality and viability.
  • HALO® QC: A 5 day complete stem cell health and quality assay. Used before and/or after processing, cryopreservation or any other manipulation (even minimal) for hematopoietic stem cell products.
  • HALO® Potency: A 7 day, FDA potency assay compliant tool to ensure and predict that a stem cell therapy product has the capability of engraftment.
  • HALO® TE: A 5 day assay to determine red blood cell, neutrophil and/or platelet engraftment.
  • HemoFLUOR™ TE: Similar to HALO®-96 TE, but using a fluorescence endpoint.
  • HemoLIGHT™ TE: Same as HemoFLUOR™-96 TE, but using an absorbance/colorimetric endpoint.
  • HALO® PMT: A 5-7 days "global" Patient Monitoring after Transplantation reconstitution assay, in which 4, 5 or 7 stem and progenitor cell populations are measured simultaneously.
  • HemoFLUOR™ PMT: Similar to HALO®-96 PMT, but using a fluorescence endpoint.
  • HemoLIGHT™ PMT: Same as HemoFLUOR™-96 PMT, but using an absorbance/coloimetric endpoint.

 

Tools for Mesenchymal Cell Regenerative Medicine

These reagents and assays can be used with any human source of mesenchymal stem cells (MSC), including iPS-derived MSCs, either fresh or cryopreserved.

 

  • CRUXRUFA™ Human Platelet Lysate: A high performance serum replacement available in 4 grades, including fibrinogen-depleted, GMP grade and GMP + Quarantine.
  • MSCGro® Medium: Available as serum-free, low serum or humanized formulations.
  • MSCGlo™ QC: A 2-3 day complete assay to determine MSC quality before and after any manipulation procedure.
  • MSCGlo™ Potency: A 2-3 day, FDA potency assay compliant tool to ensure and predict that a MSC product product has the capability to function correctly.

 

Tools for ES- or iPS-Derived Cell Products

Clinical trials are now underway to test the use and efficacy human embryonic stem (ES) cell or induced pluripotential stem (iPS) products. These products and the ES or iPS cells themselves need to be tested to ensure they are functional and viable.

 

  • STEMGlo™ Potency: A fully flexible and complete ATP bioluminescence assay kit to allow investigators to develop their own potency assay for the cell product they are using.

 

For more information on cellular therapies and regenerative medicine please click here or contact HemoGenix® directly at info@hemogenix.com or call (719) 264-6250.