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

Table 5

Ongoing clinical trials comparing BMMC and ADSC therapy in COPD.

Registry code	NCT02412332
Country	Brazil
Start year (follow-up)	April 2015 (1 year)
Status	Enrolling by invitation
Patients ()	Stage II/III COPD; age 40–70 years ()
Design	Randomized, open-label, Phase I/II safety/efficacy study
Treatment	Autologous BMMC/ADSC 1 × 10^8 in 30 ml saline by IV injection
Study arms & procedures	(1) Control (); (2) BMMC (): ~200 ml bone marrow will be surgically extracted from the pelvis under spinal anesthesia; (3) ADSC (): 50 ml of adipose tissue will be extracted by abdominal liposuction under spinal anesthesia; (4) BMMC + ADSC (): 5 × 10^7 ADSC + 5 × 10^7 BMMC in 30 ml saline; Three patients in each active treatment group will receive lung perfusion scintigraphy with technetium to evaluate cell engraftment
Primary outcomes	Efficacy: total pulmonary capacity by whole body plethysmography at 1 year
Secondary outcomes	Efficacy: pulmonary morphology (by chest X-ray) and pulmonary function (composite TLC, FVC, FEV1, FEV1/FVC, FEF 25–75, RV, TLC/RV, and airway resistance) at 9 months

BMMC, bone marrow mononuclear cell; ADSC, adipose-derived stem/stromal cell; COPD, chronic obstructive pulmonary disease; IV, intravenous; TLC, total lung capacity; FVC, forced vital capacity; FEV1, forced expiratory volume in 1 second; FEF 25–75, forced expiratory flow at 25–75% of forced vital capacity; RV, residual volume.