Table 1.

Clinical trials of mesenchymal stem cells for adult and pediatric pulmonary diseases

Disease	Study type	Age	n	MSC source	Dose	Frequency	Delivery	Follow-up	Status	Outcome	Identifier	Principal Investigator/location
Bronchopulmonary dysplasia
BPD	Phase I	Newborn (7– 14 days)	9	UCB	10 × 106/kg 20 × 106/kg	Single dose	IT	84 d/36 weeks CGA	Completed	No SAEs, ↓ BPDa	NCT01297205	Won-Soon Park, MD, PhD Samsung Medical Center, Korea
BPD	Phase I— follow-up	Newborn (7–14 days)	9	UCB	10 × 106/kg 20 × 106/kg	Single dose	IT	2 years	Completed	No sequelae, ↑ growth	NCT01632475	Won-Soon Park, PhD Samsung Medical Center, Korea
BPD	Phase I — follow-up	Newborn (7– 14 days)	9	UCB	10 × 106/kg 20 × 106/kg	Single dose	IT	5 years	Active, not recruiting	N/A	NCT02023788	Won-Soon Park, PhD Samsung Medical Center, Korea
BPD	Phase II	Newborn (7–14 days)	70	UCB	10 × 106/kg	Single dose	IT	84 d/36 weeks CGA	Unknown	N/A	NCT01828957	Won-Soon Park, PhD Samsung Medical Center, Korea
BPD	Phase II—follow-up	Newborn (7–14 days)	70	UCB	10 × 106/kg	Single dose	IT	5 years	Recruiting	N/A	NCT01897987	Won-Soon Park, PhD Samsung Medical Center, Korea
BPD	Phase I/II	Newborn (7–14 days)	12	UCB	10 × 106/kg 20 × 106/kg	Single dose	IT	84 d/20 mo CGA	Active, not recruiting	N/A	NCT02381366	Steven Powell, MD Rush University Medical Center, USA
BPD	Phase I	Infant (1–6 months)	10	UC	3 × 106/kg	Single dose	IT	1 year	Unknown	N/A	NCT01207869	Bai-Horng Su, MD, PhD China Medical University Hospital, China
BPD	Phase I	Newborn (>14 days)	10	Unknown	5 × 106/kg	Repeated doses	IT	2 years	Not yet recruiting	N/A	NCT02443961	Maria Jesus del Cerro, PhD Hospital Universitario Ramón y Cajal, Spain
Acute respiratory distress syndrome
ARDS	Phase I	Adult (18–90 years)	20	Adipose	1 × 106/kg	Single dose	IV	1 mo	Unknown	N/A	NCT01902082	Jianguo Xu, PhD Shaoxing Second Hospital, China
ARDS	Phase I/II	Adult (35–70 years)	20	UC	Unknown	Single dose	IV	2 weeks	Recruiting	N/A	NCT02444455	Huiying Liu, MD Affiliated Hospital to Academy of Military Medical Sciences, China
ARDS	Phase I	Adult (>18 years)	9	BM	1 × 106/kg 5×106/kg 10 × 106/kg	Single dose	IV	1 year	Completed	No SAEs	NCT01775774	Michael Matthay, MD University of California, San Francisco, USA
ARDS	Phase II	Adult (>18 years)	60	BM	10 × 106/kg	Single dose	IV	1 year	Recruiting	N/A	NCT02097641	Michael Matthay, MD University of California, San Francisco, USA
ARDS	Phase II	Adult (20–80 years)	10	BM	Unknown	Single dose	IV	1 mo	Recruiting	N/A	NCT02112500	Sang Bum Hong, MD Asan Medical Center, Korea
ARDS	Phase I/II	Adolescent/adult (>16 years)	75	UC	Unknown	Single dose	IV	1 mo	Not yet recruiting	N/A	NCT03042143	Danny McAuley, MD Belfast Health and Social Care Trust, Ireland
ARDS after BMT	Phase II	Adult (>18 years)	50	Unknown	3 × 106/kg	Single dose	IV	1 mo	Recruiting	N/A	NCT02804945	Amanda Olson, MD University of Texas MD Anderson Cancer Center, USA
Obstructive lung diseases
Emphysema	Phase I	Adolescent/adult (16–70 years)	12	BM	60 × 106	Single dose	IT	1 year	Unknown	N/A	NCT01758055	Paritash Tahmaseb Pour, MD, Hoda Madani, MD Masih-Daneshvari Hospital, Iran
Emphysema	Phase I	Adult (40–65 years)	10	BM	Unknown	Single dose	IV	1 year	Completed	No SAEs, no fibrosis or tumor formation		NCT01306513 Jan Stolk, MD, PhD Leiden University Medical Center, The Netherlands
Emphysema	Phase I/II	Adult (35–75 years)	30	BM	200 × 106	Repeated doses	IV	2 years	Recruiting	N/A	NCT01849159	Alexander V Averyanov, MD, PhD Federal Research Clinical Center of Federal Medical and Biological Agency, Russia
COPD	Phase I/II	Adult (40–80 years)	20	Adipose	Unknown	Single dose	IV	1 year	Recruiting	N/A	NCT02645305	Phuong Le Thi Bich, MSc, MD, Chien Vo Duc, MD Van Hanh Hospital, Vietnam
COPD	Phase II	Adult (40–80 years)	62	BM	100 × 106	Repeated doses	IV	2 years	Completed	No SAEs, ↓ CRP	NCT00683722	Mesoblast International Sàrl—Multiple Sites USA
Bronchiectasis	Phase I	Adult (30–87 years)	6	BM	20 × 106 100 × 106	Single dose	IV	1 year	Recruiting	N/A	NCT02625246	Marilyn K Glassberg, MD University of Miami, USA
Restrictive lung diseases
IPF	Phase I	Adult (40–80 years)	8	Placenta	1 × 106/kg 2×106/kg	Single dose	IV	6 months	Completed	No SAEs, no tumor formation	NCT0138564	4 Daniel Chambers, MBBS, MD The Prince Charles Hospital Australia
IPF	Phase I	Adult (30–80 years)	17	BM	Unknown	Single dose	IV	1 year	Active, not recruiting	N/A	NCT01919827	Clinica Universidad de Navarra, Spain
IPF	Phase I	Adult (40–90 years)	25	Unknown	2 × 106 100 × 106 200 × 106	Single dose	IV	60 wks	Active, not recruiting	N/A	NCT02013700	Marilyn K. Glassberg, MD University of Miami, USA
Radiation-induced PF	Phase I	Adult (18–70 years)	14	UC	1 × 106/kg	Single dose	IT	6 months	Active, not recruiting	N/A	NCT02277145	Jian Wu Dai, Ph.D Chinese Academy of Sciences, China
Pneumoconiosis	Phase I	Adult (18–70 years)	80	UC	1 × 106/kg	Single dose	IT	6 months	Recruiting	N/A	NCT02668068	Jian Wu Dai, Ph.D Chinese Academy of Sciences, China
Pneumoconiosis	Phase I	Adult (18–75 years)	10	UC	20 × 106/kg	Repeated doses	IV	1 year	Recruiting	N/A	NCT02790762	Guo Q Li, Professor The Second Affiliated Hospital of University of South China, China
Pulmonary hemonthsiderosis	Phase I	Child (1–18 years)	100	BM	Unknown	Unknown	Unknown	6 months	Not yet recruiting	N/A	NCT02985346	Weiping Tan Sun Yat-sen Memorial Hospital, China
ILD	Phase I/II	Adult (20–80 years)	20	BM	200 × 106	Repeated doses	IV	1 year	Recruiting	N/A	NCT02594839	Alexander Averyanov, MD Federal Research Clinical Center of Federal Medical and Biological Agency, Russia
IPF	Phase I/II	Adult (30–70 years)	60	Adipose	2 × 106/kg	Repeated doses	IV	9 months	Unknown	N/A	NCT02135380	Ashok A Mahashur, MBBS, MD et. al. Multiple centers, India
ILD after BMT	Phase I/II	Adult (18–65 years)	60	Unknown	1 × 106/kg	Repeated doses	Unknown	3 years	Active, not recruiting	N/A	NCT02543073	Qifa Liu, MD Nanfang Hospital of Southern Medical University, China
Cystic fibrosis
Cystic fibrosis	Phase I	Adult (18–40 years)	15	BM	1 × 106/kg 3×106/kg 5×106/kg	Single dose	IV	1 year	Recruiting	N/A	NCT02866721	James Chmiel, MD University Hospitals Cleveland Medical Center, USA
Cystic fibrosis	Phase I	Adult (20–45 years)	18	Unknown	20 × 106 100 × 106	Single dose	IV	1 year	Not yet recruiting	N/A	NCT03058068	Matthias Salathe, MD University of Miami, USA
Lung transplant/surgical
Lung transplant rejection/BO	Phase I	Adult (18–75 years)	9	Unknown	2– 4×106/kg	Single dose	IV	2 weeks	Active, not recruiting	N/A	NCT02181712	Cesar Keller, MD, Abba C Zubair, MD, PhD Mayo Clinic, USA
Lung resection	Phase I/II	Adult (18–70 years)	10	BM	Unknown	Single dose	Local	2 years	Recruiting	N/A	NCT02045745	Marcelo F Jiménez López, PhD University Clinical Hospital of Salamanca, Spain
Toxin-induced lung injury
Mustard lung	Phase I	Adult (45–65 years)	10	BM	100 × 106	Repeated doses	IV	6 months	Active, not recruiting	N/A		NCT02749448 Mostafa Ghanei, MD Baqiyatallah Medical Sciences University, Iran
Paraquat poisoning- induced LI	Phase I/II	Adolescent/adult (15–60 years)	40	UC	0.5 × 106	Repeated doses	IV	2 months	Recruiting	N/A	NCT02444858	Haochun Wang, MD et. al. Affiliated Hospital to Academy of Military Medical Sciences, China

BMT, bone marrow transplant; BO, bronchiolitis obliterans; BPD, bronchopulmonary dysplasia; COPD, chronic obstructive pulmonary disease; ILD, interstitial lung disease; IPF, idiopathic pulmonary fibrosis; LI, lung injury; MSC, mesenchymal stem cell; UC, umbilical cord; UCB, umbilical cord blood.

^aDecreased incidence of BPD compared to historical controls.