TABLE 2.
Clinical trial publications underreport MSC manufacturing details. Dashed lines represent unreported data.
| Author | Donor | Manufacturing information | Other preparation details | MSC state | Cryopreservation mode | Cryomedia formulation | |
|---|---|---|---|---|---|---|---|
| Culture media | MSC culture age | ||||||
| Amirdelfan et al. (2021) | Allogeneic | — | — | — | Frozen | — | — |
| Lanzoni et al. (2021) | Allogeneic | DMEM Low Glucose, 10% platelet gold, 1 × GlutaMAX, 1 × MEM-NEAA | — | — | Frozen | — | — |
| Bolli etal. (2018); Bolli et al. (2021) | Autologous | Lymphocyte cell separation media | — | — | Frozen | — | — |
| Soder et al. (2020) | Allogeneic | — | P5 | — | Frozen | Aliquot | Plasma-Lyte A, DMSO, HSA |
| Kurtzberg et al. (2020) | Allogeneic | — | P5 | — | Frozen | Aliquot | Plasma-Lyte A, DMSO, HSA |
| Kebriaei et al. (2020) | Allogeneic | Supplemented with 10% FBS a | P5 | — | Frozen | Bag | Plasma-Lyte, 50 g/L (5%) HSA, 10% DMSO |
| Chahal et al. (2019) | Autologous | DMEM low glucose, 1% Glutamax, 10% FBS | P3 (day 30) or P4 (day 37) | Washed 2x in Plasma-Lyte A, 1x in Plasma-Lyte A+ 2.5% patient serum (excipient) | Fresh | N/A | — |
| Schlosser et al. (2019) | Allogeneic | NutriStem XF | PDL ≤12 | Culture 5–12 days after thaw (PDL≤18) | Culture-rescued after thaw | — | — |
| Berry et al. (2019) | Autologous | — | — | 3–4 weeks culture for neurotrophic factor secretion | Fresh | N/A | 10% DMSO in growth medium, controlled rate, pre-MSC-NTF generation a |
| Dozois et al. (2019) | Autologous | — | — | Thawed to adhere to fistula plug (proprietary) | Frozen | — | — |
| Yau et al. (2019) | Allogeneic | — | — | — | Frozen | Aliquot4 × 1 ml | 7.5% DMSO, 50% α-MEM, 42.5% ProFreeze a |
| Levy et al. (2019) | Allogeneic | — | P4 | 5% O2; washed in Lactate Ringer’s solution | Frozen | Aliquot | Cryostor CS10 |
| Singer et al. (2019) | Autologous | — | — | Thaw from cryo, culture in PLTMax for 3–5 days | Culture-rescued after thaw | — | — |
| Myerson et al. (2019) | Allogeneic | — | — | — | — | — | — |
| Schweizer et al. (2019) | Allogeneic | α-MEM, 2 mM l‐glutamine, 10% FBS, no antibiotics | — | — | Frozen | Bag20 ml | 6% hetastarch in 0.9% NaCl injection, 2% HSA, 5% DMSO |
| Powell and Silvestri (2019) | Allogeneic | — | — | — | Frozen | — | — |
| Chan et al. (2020) | Autologous | α-MEM, 20% FBS, gentamicin | To P3 in 21 days | N/A | Fresh | N/A | N/A |
| Harris et al. (2018) | Autologous | Lonza NPMM | 2–3 weeks after thaw at P2-3 | Culture-rescued after thaw | — | — | |
| McIntyre et al. (2018) | Allogeneic | NutriStem XF | PDL ≤12 | Culture 5–12 days after thaw (PDL≤18) | Culture-rescued after thaw | — | — |
| Matthay et al. (2019) | Allogeneic | — | — | Wash to remove DMSO before resuspension | Frozen | Aliquot | Contains DMSO |
| Swaminathan et al. (2018) | Allogeneic | — | — | — | Frozen | Bag20 ml | 20 ml (120 M cells) PlasmaLyte A w/10% DMSO, 5% HSA, pH 7.4 a |
| Keller et al. (2018) | Allogeneic | α-MEM, 9.8% HyClone Characterized FBS | — | — | Frozen | — | 20 ml, 2.5% DMSO |
| Tompkins et al. (2017) | Allogeneic | α-MEM, 20% FBS | P1 (21–24 days) a | Wash with Plasma-Lyte A+ 1% HSA a | Fresh | N/A | N/A |
| Glassberg et al. (2017) | Allogeneic | α-MEM, 20% FBS | P1 (21–24 days) a | Washed a | Fresh and frozen | — | Pentaspan (10% pentastarch in 0.9% NaCl), 2% HSA, 5% DMSO a |
| Dietz et al. (2017) | Autologous | — | — | Thaw from cryo, bioreactor 3–6 days for plug adherence | Culture-rescued after thaw | — | — |
| Golpanian et al. (2017) | Allogeneic | α-MEM, 20% FBS | P1 (21–24 days) a | Wash with Plasma-Lyte A+ 1% HSA a | Fresh | N/A | N/A |
| Florea et al. (2017) | Allogeneic | α-MEM, 20% FBS | P1 (21–24 days) a | — | Frozen | — | Pentaspan (10% pentastarch in 0.9% NaCl), 2% HSA, 5% DMSO a |
| Saad et al. (2017) | Autologous | Isolated 6 weeks prior, 2 weeks in Advanced MEM with PLTMax (5% platelet lysate, 100 U/ml penicillin, 100 g/ml streptomycin, 2 mM l-glutamine) | — | N/A | Fresh | N/A | N/A |
| Butler et al. (2017) | Allogeneic | — | — | Hypoxia | Frozen | — | Cryostor CS10 |
| Bajestan et al. (2017) | Autologous | IMDM, 10% FBS, 10% horse serum, 5 mM hydrocortisone | 12 days in bioreactor | N/A | Fresh | N/A | N/A |
| Hare et al. (2017) | Autologous and Allogeneic | α-MEM, 20% FBS | P1 (21–24 days) a | — | Frozen | — | Pentaspan (10% pentastarch in 0.9% NaCl), 2% HSA, 5% DMSO a |
| Harris et al. (2016) | Autologous | 2–3 passages/7–54 days in Lonza MSCGM +10% patient serum, plus 7–24 days in Lonza NPMM | N/A | Fresh | N/A | N/A | |
| Steinberg et al. (2016) | Allogeneic | — | — | — | — | — | — |
| Dhere et al. (2016) | Autologous | α-MEM, 10% HSA | P1 | N/A | Fresh | N/A | N/A |
| Staff et al. (2016) | Autologous | Advanced MEM, 5% hPL | <P5 | — | Frozen | Aliquot | — |
| Castillo-Cardiel et al. (2017) | Autologous | DMEM, 10% FBS, antibiotics | 24 h | N/A | Fresh | N/A | N/A |
| Coetzee et al. (2016) | Allogeneic | — | — | — | — | — | — |
| Patel et al. (2016) | Autologous | — | 12 days in bioreactor | N/A | Fresh | N/A | N/A |
| Levy et al. (2016) | Allogeneic | — | — | — | — | — | — |
| Perin et al. (2015) | Allogeneic | — | P5 or <20 PDL | — | Frozen | Aliquot4 × 1 ml | 4% DMSO, 50% α-MEM, 42.5% ProFreeze |
| Levy et al. (2015) | Allogeneic | — | — | — | — | — | — |
| Skyler et al. (2015) | Allogeneic | Media (unspecified), FBS | — | — | Frozen | — | 4% DMSO, 50% α-MEM, 42.5% ProFreeze |
| Wilson et al. (2015) | Allogeneic | — | — | Frozen | — | Contains DMSO | |
| Maziarz et al. (2015) | Allogeneic | FBS | — | Wash in HSA before cryo | Frozen | — | Contains DMSO |
| Pettine et al. (2015) | Autologous | — | — | — | — | — | — |
a
Denotes publications which have information referenced in external references or supplemental material. Abbreviations: cryo, cryopreservation; DMSO, dimethylsulfoxide; FBS, fetal bovine serum; HSA, human serum albumin; IM, intramuscular; IV, intravenous; M, million; MEM, modified eagle medium (D, Dulbecco’s); MSC, mesenchymal stromal cell; N/A, not applicable; NaCl, sodium chloride; NEAA, non-essential amino acids; NTF, neurotrophic factor-secreting; P, passage; PDL, population doubling level.