Mesenchymal Stem Cell Administration in Patients with Chronic Obstructive Pulmonary Disease: State of the Science

Table 3

Ongoing clinical trials with ADSC administration in COPD.

Registry code	NCT02041000	NCT01559051	NCT02161744	NCT02216630	NCT02135380	NCT02645305	NCT02348060
Country	USA	Mexico	USA	USA	India	Vietnam	USA
Start year; (follow-up)	January 2014; (6 months)	March 2014; (6 months)	May 2014; (1 year)	August 2014; (1 year)	August 2014; (9 months)	June 2015; (1 year)	November 2015; (1 year)
Status	Recruiting	Recruiting	Recruiting	Recruiting	Unknown	Recruiting	Recruiting
Patients ()	Stage III/IV COPD; age 18–85 years ()	Stage III/IV COPD; age 18–80 years ()	COPD; age ≥ 18 years ()	Stage IIa/III/IV COPD; age 18–85 years ()	IPF, COPD; age 30–70 years ()	Stage IIa/III/IV COPD, age 40–80 years ()	COPD; age ≥ 18 years ()
Design	Multicenter, open-label, nonrandomized safety/efficacy study	Multicenter, open-label, nonrandomized, Phase I/II safety/efficacy study	Multicenter, open-label, nonrandomized, Phase I safety/efficacy study	Open-label, nonrandomized, Phase I/II, safety/efficacy study	Multicenter, open-label, randomized, Phase I/II safety/efficacy study	Open-label, safety/efficacy study	Prospective observational cohort study
Treatment (cells, dose & delivery route)	ADSC	Autologous AD-SVF; IV infusion & inhaled	Autologous AD-SVF; single IV injection	Autologous AD-SVF; IV injection	Autologous AD-SVF/AD-MSC; IV injection	Autologous AD-SVF & PRP; IV injection	Autologous AD-SVF; Single IV injection
Study arm(s); (procedure)	Single arm: ADSC therapy	Single arm: ADSC therapy (lipoaspiration with local anesthesia)	Single arm: ADSC therapy (lipoaspiration & IV SVF saline suspension)	Single arm: ADSC therapy (lipoaspiration)	Randomized: SVF; AD-MSCs; standard therapy (control)	Single arm: ADSC & PRP	Single arm: ADSC therapy (lipoaspiration)
Primary outcomes	Safety: AEs occurrence/frequency at follow-up; Efficacy: SGRQ QoL at follow-up	Efficacy: 6MWT at 3 & 6 months; Safety: number of AEs at 3 & 6 months	Safety: frequency of AEs and SAEs at follow-up	Efficacy: FEV1 decline of ≤30 mL at follow-up; Safety: number of AEs at follow-up	Safety: treatment emergent AE rates at follow-up	Safety: SGOT, SGPT at 1 month	Efficacy: CRQ-SAI at 1 year
Secondary outcomes	Efficacy: GOLD-classified airflow obstruction & 6MWT at follow-up	Efficacy: SGRQ at 3 & 6 months	Efficacy: less decrease of FEV1 (ml), FEV1/FVC (%), DLCO (%) & 6MWT (mm) at 6 weeks to 1 year	Efficacy: decrease in 6MWD of <5% over 1 year	Efficacy: change in predicted FVC (%) & DLCO (%), changes in 6MWT & disease extent and severity (HRCT) at follow-up	Efficacy: respiration rate, 6MWT, panic attack rate, and CRP concentration at 1, 6 & 12 months	Efficacy: CRQ-SAI dyspnea, fatigue, emotional function, and mastery subscales at 12 months

COPD, chronic obstructive pulmonary disease; ADSC, adipose-derived stem/stromal cell; AE, adverse event; SGRQ, St. George Respiratory Questionnaire; QoL, quality of life; 6MWT, six-minute walk test; IV, intravenous; AD-SVF, adipose-derived stromal vascular fraction; SVF, stromal vascular fraction; SAE, severe adverse event; FEV1, forced expiratory volume in 1 second; DLCO, diffusing lung capacity for carbon monoxide; IPF, idiopathic pulmonary fibrosis; AD-MSC, adipose-derived mesenchymal stem/stromal cell; FVC, forced vital capacity; HRCT, high-resolution computed tomography; PRP, platelet-rich plasma; SGOT, serum glutamic oxaloacetic transaminase; SGPT, serum glutamic pyruvic transaminase; CRP, C-reactive protein; CRQ-SAI, Chronic Respiratory Disease Questionnaire-Self-Administered Individualized.