Stem Cells International

Review Article

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

Table 4

Ongoing clinical trials with BM-MSC administration in COPD.


Registry code	NCT01758055	NCT01872624	NCT01849159

Country	Iran	Brazil	Russia

Start year (follow-up)	December 2012 (1 year)	May 2013 (4 months)	March 2014 (2 years)

Status	Unknown	Completed (March 2015)	Recruiting

Patients ()	Moderate to severe emphysema; age 16–70 years ()	Pulmonary emphysema (severe heterogeneous emphysema); age ≥ 18 years ()	Stage III/IV pulmonary emphysema ()

Design	Single arm, open-label, Phase I safety study	Nonrandomized, open-label, Phase I safety study	Randomized, open-label, Phase I/II safety/efficacy study

Treatment	Autologous BM-MSC; single IB injection of 6 × 10⁶ cells by bronchoscopy	Autologous BM-MSC; IB injection by bronchoscopy	Allogeneic BM-MSC; 2 × 10⁸ cells (hypoxic-preconditioned in 1% oxygen); IV infusion every 2 months for 1-year

Study arm(s)	BM-MSC therapy	Valves + BM-MSC treatment () versus valves + saline controls ()	BM-MSC suspension versus placebo (400 ml 0.9% saline)

Primary outcomes	Safety: FVC, FEV1, and FEV1/FVC at 1 year	Safety: absence of lung deficits during the procedure and/or follow-up	Safety: mortality, AEs & treatment reactions, and vital signs (pulse, arterial blood pressure) at 1 year

Secondary outcomes	Safety: 6MWT at 1 year Others: oxygen saturation: oximeter test, SF-36 QoL, DLCO, and CT scan; MMRC dyspnea score, blood gases PaO₂& PaCO₂, CBC test, at baseline and 1 year	Safety: SGRQ QoL; Pulmonary function: spirometry, flow-volume curve, postbronchodilator test, RV, airway resistance by plethysmography, DLCO & 6MWT Inflammation: serum CRP, erythrocyte at 4 months	Lung tissue density: CT-densitometry Pulmonary function: DLCO, FEV1, TLC, RV, and FEV1/FVC Physical capacity: 6MWT Blood gases: PaO₂, PaCO₂Serum IL-6, TNF-α, leptin QoL: SF-36 Number and frequency of exacerbationsBody mass index at follow-up

BM-MSC, bone marrow-derived mesenchymal stem/stromal cell; COPD, chronic obstructive pulmonary disease; IB, intrabronchial; FVC, forced vital capacity; FEV1, forced expiratory volume in 1 second; 6MWT, six-minute walk test; SF-36, Medical Outcomes Study Questionnaire Short Form 36 Health Survey; QoL, quality of life; DLCO, diffusing lung capacity for carbon monoxide; CT, computerized tomography; MMRC, modified Medical Research Council; PaO₂, partial pressure of oxygen; PaCO₂, partial pressure of carbon dioxide; CBC, complete blood count; SGRQ, St. George Respiratory Questionnaire; CRP, C-reactive protein; IV, intravenous; AE, adverse event; TLC, total lung capacity; RV, residual volume.