TABLE 1.
Clinical trial publications inconsistently report details relevant to MSC dose preparation and bedside handling. Dashed lines represent unreported data.
| Author | Administration Route | Cell dose | Cell delivery buffer | Rate and/or duration of administration | Dose and/or delivery detail | Prep-to-admin storage and timing | |
|---|---|---|---|---|---|---|---|
| # per kg | Mean # | ||||||
| Amirdelfan et al. (2021) | Intradiscal | — | 6 or 18 M | Hyaluronic acid (HA) carrier | — | 2 ml (1 ml of 30 or 90 M cells/5 ml + 1 ml 1% HA) | Thawed and combined with HA carrier at time of administration |
| Lanzoni et al. (2021) | IV | — | 100 ± 20 M | Plasma-Lyte, HSA, Heparin | 10 ± 5 min | 2 × 50 ml dose Plasma-Lyte, HSA, Heparin (D0, D3) | Thaw quickly, less than 3 h from thaw to administration |
| Bolli etal. (2018); Bolli et al. (2021) | Endocardial injections | — | 75–150 M | Plasma-Lyte | — | 6 ml | — |
| Soder et al. (2020) | IV | — | — | — | — | — | Thawed immediately on day of administration |
| Kurtzberg et al. (2020) | IV | 2 M | 50 M | Plasma-Lyte A | 1 h | 50 ml dose | Thawed and resuspended immediately before administration |
| Kebriaei et al. (2020) | IV | 2 M | — | Plasma-Lyte, 50 g/L (5%) HSA, 10% DMSO | 4–6 ml/min | — | Thawed and immediately infused |
| Chahal et al. (2019) | Intraarticular | — | 1, 10 or 50 M | 2.5% patient serum in Plasma-Lyte A | — | Dose in 6.5 ml+/- 1.5 ml | 15–25°C for 8 h in Plasma-Lyte A then 2–10°C for 24 h |
| Schlosser et al. (2019) | IV | 0.3, 1 or 3 M (total ≤300 M) | — | 80% Plasma-Lyte A, 20% Alburex-25 human albumin | 20 min (10 ml), 40 min (35 ml) or 60 min (100 ml) by dose cohort | — | — |
| Berry et al. (2019) | IT and IM injection (bicep and tricep) | — | 125 M IT, 48 M IM | Culture media (DMEM) | — | 5 ml IT and 1 ml × 24 IM; DMEM placebo | Validated shipping system at controlled temperature 2–8°C |
| Dozois et al. (2019) | Fistula plug | — | 20 M/plug | Maintained in Lactated Ringer’s solution until delivery | — | — | — |
| Yau et al. (2019) | Intramyocardial | — | 150 M | Cryoprotective medium as sham | 15 min | 16–20 injections of 0.2 ml | Thawed longer than 90 min discarded |
| Levy et al. (2019) | IV | 0.5, 1, or 1.5 M | — | Lactated Ringer’s solution | 2 ml/min | 1 M cells/ml in 1–3 × 60 ml syringes; 0.1 ml intradermal for patient reactivity prior | Stored at 2 to 8°C and infused within 8 h |
| Singer et al. (2019) | IT | — | 10 M, 2 × 50 M or 2 × 100 M | Lactated Ringer’s solution | 1–2 min | Dose followed by 1 ml flush | Used within 12 h of preparation |
| Myerson et al. (2019) | Arthrodesis surgery | N/A (device) | — | — | — | — | — |
| Schweizer et al. (2019) | IV | 1 M or 2 M (max 100 M or 200 M total) | — | 6% hetastarch in 0.9% NaCl injection, 2% HSA, 5% DMSO | — | — | — |
| Powell and Silvestri (2019) | Intratracheal | 10 M (2 ml/kg in 2 aliquots) or 20 M (4 ml/kg in 4 aliquots) | — | Normal saline | 5–10 min | 5 M/ml | Administered within 3 h of thawing and resuspension |
| Chan et al. (2020) | Intramyocardial | — | Targeted 150 M, minimum 15 M | 0.9% NaCl | — | 3 ml in 30 × 100 µl | — |
| Harris et al. (2018) | IT | — | 5.3–10 M (3 doses 3 months apart) | Saline | — | — | — |
| McIntyre et al. (2018) | IV | 0.3, 1 or 3 M to max of 300 M | — | 80% Plasma-Lyte A, 20% Alburex-25 human albumin | 20 min (10 ml), 40 min (35 ml) or 60 min (100 ml) by dose cohort | — | — |
| Matthay et al. (2019) | IV | 10 M | — | Plasma-Lyte A | 60–80 min | 100 ml dose | — |
| Swaminathan et al. (2018) | Intraaortic | 2 M | — | 10% DMSO, 5% HSA in Plasma-Lyte A, pH 7.4 a | 1–3 min | 100 ml dose | On refrigerated gel packs and administration within 8 h preparation |
| Keller et al. (2018) | IV | 1, 2 or 4 M | 5 M | Plasma-Lyte, 0.5% DMSO | 2–3 ml/min during the first 15 min, with the option to be adjusted up to 5 ml/min if tolerated | Cells diluted 5-fold in 100 ml | — |
| Tompkins et al. (2017) | IV | — | 100 or 200 M | 0.9% saline a | 2 ml/min | 100 ml; squeeze infusion bag every 15 min, 25 ml flush at end | — |
| Glassberg et al. (2017) | IV | — | 20, 100 or 200 M | PBS, 1% HSA a | — | — | Cryo: thaw in 37°C water bath, wash, resuspended; Fresh: resuspended a |
| Dietz et al. (2017) | Fistula plug | — | 20 M per plug | Lactated Ringer’s solution | — | — | — |
| Golpanian et al. (2017) | IV | — | 20, 100 or 20 M | 0.9% saline a | 2 ml/min | 100 ml; squeeze infusion bag every 15 min, 25 ml flush at end | — |
| Florea et al. (2017) | Transendocardial | — | 20 or 100 M | PBS +1% HSA or Plasma-Lyte A+ 1% HSA a | — | 20 M/ml; 0.5 cc per injection × 10 | Thaw at 37°C in water bath, pellet resuspended a |
| Saad et al. (2017) | Intraarterial | 0.1 or 0.25 M | — | Lactated Ringer’s solution | 5 min | 10 ml | — |
| Butler et al. (2017) | IV | 1.5 M | — | Lactated Ringer’s solution | — | 1M/ml, 1 ml/kg | Thawed within pharmacy, infusion within 8 h |
| Bajestan et al. (2017) | Alveolar graft | — | 15–44 M/ml, 2–5 ml/patient | Isolyte +0.5% HSA mixed with b-TCP carrier | — | 10 ml ixmyelocel-t in Isolyte +0.5% HSA mixed with b-TCP carrier; 2.5 ml/patient | At 4°C for up to 40 h |
| Hare et al. (2017) | Transendocardial | — | 100 M (≥80 M autologous) | PBS +1% HSA or Plasma-Lyte A+ 1% HSA a | 0.4 ml/min, 10 × 0.5 ml each | 20 M/ml | Thaw at 37°C in water bath, pellet resuspended a |
| Harris et al. (2016) | IT | — | — | Saline with CSF | — | Saline with 3 ml CSF then 2 ml CSF flush | — |
| Steinberg et al. (2016) | Post-craniostomy implant | — | 2.5, 5 or 10 M | — | 10 µl per minute, 15 min per track × 3 tracks | — | — |
| Dhere et al. (2016) | IV | 2, 5 or 10 M | — | Plasma-Lyte A with 0.05% HSA | Roughly 60 min | 4 M cells/ml | — |
| Staff et al. (2016) | IT | — | 10, 50, 50 M × 2, 100 M | Lactated Ringer's solution | 1‐2 min | 2 or 10 ml | Administered post-thaw or post-thaw + 4 days |
| Castillo-Cardiel et al. (2017) | To mandibular fracture line pre-open reduction and internal fixation (ORIF) | — | 10–600 M from 50cc adipose tissue | — | — | — | — |
| Coetzee et al. (2016) | Arthrodesis surgery | N/A (device) | — | — | — | — | — |
| Patel et al. (2016) | Transendocardial | — | 35–295 M a | — | — | 5.8–8.4 ml was delivered as a series of 12–17 injections of 0.4 ml each a | — |
| Levy et al. (2016) | Corpora cavernosum base injection | — | 1 ml product (# not quantified) | Isotonic saline | — | 1.5 ml of 3 ml dilution | — |
| Perin et al. (2015) | Transendocardial | — | 25, 75 or 150 M | Cryoprotective medium as sham a | — | 16–20 injections of 0.2 ml | — |
| Levy et al. (2015) | Peyronie plaques, corpora injection | — | — | Isotonic saline | — | Up to 2 ml of 3 ml dilution | — |
| Skyler et al. (2015) | IV | 0.3, 1 or 2 M | — | Normal saline | 45 min | 100 ml | Thawed immediately before use |
| Wilson et al. (2015) | IV | 1, 5 or 10 M | — | Plasma-Lyte A | 60–80 min | 100 ml | 2 h of stability, then 60–80 min gravity feed |
| Maziarz et al. (2015) | IV | 1, 5 or 10 M (repeat 1 or 5M × 3/week or 5M × 5/week | — | Plasma-Lyte A, 5% DMSO | 5–10 ml/min | 23–61 ml or 100–143 ml or 133–294 ml (diluted based on body weight) | Infused within 6 h after thaw |
| Pettine et al. (2015) | Intradiscal | — | ∼726 M (121 ± 11 M/ml × 6) | Non-expanded BM concentrate | — | 6 ml | — |
a
Denotes publications which have information referenced in external references or supplemental material. Abbreviations: BM, bone marrow; D, day; DMSO, dimethylsulfoxide; FBS, fetal bovine serum; HSA, human serum albumin; IM, intramuscular; IT, intrathecal; IV, intravenous; M, million; MEM, modified eagle’s media; min, minute; N/A, not applicable; NaCl, sodium chloride; NEAA, non-essential amino acids; P, passage; PBS, phosphate buffered saline; PDL, population doubling level.