Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study

Table 2

MSC-HF II study: summary of events.

Event	Screening/baseline	D1	D2	D3	M1	M3	M6	M12
Informed consent	X
History/physical	X	X		X	X	X	X	X
NYHA	X	X			X	X	X	X
CCS	X	X			X	X	X	X
ECG	X	X		X	X	X	X	X
Biochemistry local laboratory	X	X	X	X	X	X	X	X
Biomarkers	X	X			X	X	X	X
HLA tissue typing	X
HLA tissue antibodies	X				X	X	X	X
6-minute walking test	X					X	X	X
Chest X-ray	X
CCT	X						X	X
KCCQ	X					X	X	X
SAQ	X					X	X	X
EQ5D3L	X					X	X	X
NOGA mapping			X
IMP injection			X
Echocardiography	X		X				X
Holter monitoring	X	X	X	X
AE evaluation			X	X	X	X	X	X

D: day; M: month; AE: adverse events; CCS: Canadian Cardiovascular Society functional classification; CCT: cardiac computed tomography imaging; ECG: electrocardiogram; HLA: humane leucocyte antigen; IMP: investigational medicinal product; KCCQ: Kansas City Cardiomyopathy Questionnaire; NYHA: New York Heart Association functional classification; SAQ: Seattle Angina Questionnaire. EQ5D3L questionnaire.