Topical and intravenous administration of human umbilical cord mesenchymal stem cells in patients with diabetic foot ulcer and peripheral arterial disease: a phase I pilot study with a 3-year follow-up

Table 2 Study schedule and procedure

Study items	Screening	Treatment			Follow-up
		Inj 1	Inj 2	Inj 3	FU1	FU2	FU3	FU4	FU5	FU6
		D 0	D 7	D 28	M 1.5	M 3	M 6	M12	M24	M36
Informed consent	×
Medical history	×				×	×	×	×	×	×
Concomitant medicine	×	×	×	×	×	×	×	×	×	×
AE	×	×	×	×	×	×	×	×	×	×
PE	×	×	×	×	×	×	×	×	×	×
Vital signs	×	×	×	×	×	×	×	×	×	×
Fundus exam	×						×	×	×	×
Wagner grade	×		×	×	×	×	×	×
Rutherford grade	×		×	×	×	×	×	×
CTA	×				×			×
ECG	×		×	×	×	×	×	×	×	×
BR	×		×	×	×	×	×	×	×	×
Biochemistry	×		×	×	×	×	×	×	×	×
HbA1c	×				×	×	×	×	×	×
Uroglucose	×		×	×	×	×	×	×	×	×
UR	×		×	×	×	×	×	×	×	×
Serologic assays ^a	×
hUC-MSC injection		×	×	×

^aSerologic assays were performed in screening visit, including: detection for anti-HAV, anti-HBc, anti-HBe, anti-HBs, HBsAg, HBeAg, anti-HCV, and anti-HIV; FTA-ABS test; procalcitonin, CRP, ESR, and anti-ENA antibody
AE adverse event, anti-HBc antibody to hepatitis B virus core antigen, anti-HBe antibody to hepatitis B virus e antigen; anti-HBs, hepatitis B virus surface antibody; BR, blood routine test; CRP, C-reactive protein; CTA, computed tomography angiography; ECG, electrocardiogram; ENA, extractable nuclear antigen; ESR, erythrocyte sedimentation rate; FTA-ABS, fluorescent treponemal antibody absorption; HbA1c, hemoglobin A1c; hUC-MSC, human umbilical cord mesenchymal stem cell; HAV, hepatitis A virus; HBeAg, hepatitis B virus e antigen; HBsAg, hepatitis B virus surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; Inj, injection, PE, physical exams; UR, urine routine test

ISSN: 1757-6512