Table 1. Comparison of BMSC manufacturing methods used by the 8 Centers.
Center | Donor Type | Marrow Source | Density Gradient Separation | Culture Media | Vessels | Number of Passages |
---|---|---|---|---|---|---|
1 | Healthy Subjects | Marrow Aspirate | No | DMEM* 5% Human Platelet Lysate 2 mM GlutaMax 10 mM N-acetyl cysteine 2 IU/mL heparin | Quantum Bioreactor | 2 |
2 | Healthy Subjects | Marrow Aspirate | No | Alpha MEM# 10% FBS+ 5 ng/mL bFGF GlutaMax | T-Flasks | 3 |
3 | Healthy Subjects | Marrow Aspirate | Yes | IMDM* 10% “hBM MSC” Supplement^ | T-Flasks | 4 |
4 | Healthy Subjects | Cryopreserved Marrow Aspirate | No | Alpha MEM 10% FBS+ Glutamax | T-Flasks | 3 |
5 | Healthy Subjects | Marrow Aspirate | Yes | Alpha MEM 16.5% FBS+ 1xGlutaMax | T-Flasks and Multiple Layer Flasks | 2 |
6 | Healthy Subjects | Marrow Aspirate | No | Alpha MEM with UltraGlutamine 20% FBS+ | T-Flasks and Multiple Layer Flasks | 4 |
7 | Healthy Subjects and Organ Donors | Fresh or Cryopreserved Marrow Aspirate | Yes and No | Alpha MEM 10% FBS+ GlutaMax | T-Flasks | 2 to 3 |
8 | Healthy Subjects | Marrow Aspirate | Yes | Alpha MEM 10% FBS+ GlutaMax | T-Flasks and Multiple Layer Flasks | 5 |
*Dulbecco’s Modified Eagle Medium.
#Minimum Essential Medium.
*Iscove’s Modified Dulbecco’s Media.
^Stem Cell Technologies.
+FBS was not heat-inactivated.