Table 3.

A detailed note on the clinical trials on stem cell therapy in ALI or ARDS

Stem cell therapy	Route of delivery (dose)	Stage of the trial	No of patients	Results	Control	Country	Follow up period	References
AD-MSCs	Intravenous (1 × 106 cells/kg)	Phase I	20	∙ Lower levels of IL-6 and SP-D (surfactant protein D) was observed ∙ No infusion toxicities or serious adverse events related to MSCs administration was observed	Triple masking Placebo—Saline infusion	China	28 days	[139]
	Intravenous (1 × 106 cells/kg and 2 × 106 cells/kg)	Phase I and II	26	–	Quadruple masking Placebo—Saline infusion	Spain	1 year	[202]
UC-MSCs	Intravenous (1 × 106 cells/kg)	–	26 (Recruiting)	–	Placebo—Normal saline	China	60 days	[203]
	Intravenous Low dose Medium dose High dose	Phase I	18	–	Open label	Taiwan	3 months	[204]
	Intravenous (5 × 105 cells/kg) three doses per day	Phase I and II	20	–	Open label	China	14 days	[205]
	Intravenous (5 × 107 cells/kg) and standard treatment	Phase I and II	40	–	Quadruple masking Control—Standard treatment (hydroxychloroquine + Lopinavir/Ritonavir or Azithromycin and ventilation support) and placebo	Colombia	6 months	[206]
STem cells for ARDS Treatment (START) trials	Phase I—Intravenous ∙ Low dose- 1 × 106 cells/kg ∙ Moderate dose- 5 × 106 cells/kg ∙ High dose-10 × 106 cells/kg Phase 2a—Intravenous ∙ High dose-10 × 106 cells/kg	Phase I and Phase 2a completed	Phase I—9 patients (3 in each category) Phase 2a—60 patients	∙ All patients had no adverse effect on MSC infusion ∙ No significant changes were observed in mean serum creatinine, total bilirubin, ALT, arterial pressure ∙ 2 patients expired and one patient had a severe adverse effect (Not because of MSC transplantation) in Phase I and 1 patient died in Phase 2a for unrelated reasons ∙ Phase I showed a decline in lung injury score (LIS) was highest in the high dose patients ∙ Phase I showed reduced levels of IL-6, RAGE, and Ang-2	–	USA	6 months	[59, 207, 208]
BM-MSCs	Intravenous (3 × 106 cells/kg)	Phase I completed	20	–	Open label	USA	30 days	[209]
	Intravenous	Phase II	10	–	Open label	South Korea	28 days	[210]
MB-MSCs	Intravenous (10 × 107 cells/kg) four times in 2 weeks	Phase I and II	20	–	Open label	China	14 days	[28]
Cymera MSCs (iPSC and mesenchymoangioblast (MCA)-derived cells)	Intravenous (2 × 106 cells/kg)	Phase I and II	Recruiting (24)	–	Open label	Australia	28 days	[98]