Preliminary evidence of renal function improvement in chronic progressive kidney disease using autologous CD34+ cell therapy: A clinical trial

Table 1 Baseline characteristics

Characteristics	Value
Age (year), mean ± SD	68.5 ± 1.7
Male/female (n)	3:1
Underlying disease, n (%)
IgA nephropathy	3
Non-IgA mesangial proliferative GN	1
Comorbidity, n (%)
Ischemic heart disease	0 (0)
Stroke	0 (0)
Hypertension	3 (75.0)
Diabetes	0 (0)
Dyslipidemia	1 (25.0)
Smoking habit, n (%)
No	4 (100.0)
Yes	0 (0)
Body mass index (kg/m2), median (IQR)	20.3 (18.6-22.2)
Laboratory valuables, median (IQR)
Blood urea nitrogen (mg/dL)	36.5 (24.6-53.5)
Creatinine (mg/dL)	2.42 (2.01-2.98)
eGFR (mL/min/1.73 m2)	19.5 (15.1-26.8)
Total protein (g/dL), mean ± SD	6.1 ± 0.2
Albumin (g/dL), mean ± SD	3.9 ± 0.2
Total cholesterol (mg/dL),	221.0 (196.5-242.5)
Triglyceride (mg/dL)	113.5 (70.5-177)
HDL-cholesterol (mg/dL)	65.7 (47.2-85.5)
LDL-cholesterol (mg/dL)	118.0 (109-124)
Hemoglobin (g/dL)	12.0 (11.5-14.4)
Urinary protein/creatinine ratio (g/gCr)	0.91 (0.1-1.3)
Urinary blood, grade (%)	1+ (100.0)
Urinary 2 microglobulin (g/L)	1051.5 (183.9-2975.8)
Urinary NGAL/creatinine ratio (microgram/gCr)	17.5 (10.5-28.0)
Medication, n (%)
ARB	4 (100.0)
ACEi	0 (0)
SGLT2 inhibitor	2 (50.0)

IgA: Immunoglobulin A; eGFR: Estimated glomerular filtration rate; IQR: Interquartile range; HDL: High-density lipoprotein; LDL: Low-density lipoprotein; NGAL: Neutrophil gelatinase-associated lipocalin; ARB: Angiotensin receptor blocker; ACEi: Angiotensin converting enzyme inhibitor; SGLT2: Sodium glucose cotransporter 2.

Table 2 Information about cell product

Cell product		Case 1		Case 2		Case 3		Case 4
		1st	2nd	1st	2nd	1st	2nd	1st	2nd
Apheresis product	Total MNC number (× 1010)	6.3	5.5	14.5	11	11.7	8.9	13.7	16.9
	CD34+ cell number (× 107)	9.5	10.9	6.1	6.4	43.3	32.6	23.5	19.9
Cell product after magnetic sorting	CD34+ cell number (× 107)	5.5	7.6	1.3	0.9	27.3	22.4	8.9	2.5
	Viability (%)	97.3	98.5	96.9	97.2	97.9	98.3	98.2	96.4
	CD34+ cell purity (%)	52.7	60.7	84.6	89.2	94.6	81.6	86.7	93.0
Administered cell number (× 107)		4.0	4.0	1.3	0.9	5.2	5.2	7.3	2.5

MNC: Mononuclear cell.

Table 3 Adverse events

	Adverse event	CTCAE grade	Treatment	Related factor
Case 2	Left hip joint pain and left femoral bone pain	Grade 1	Acetaminophen	G-CSF
Case 3	Fever	Grade 1	Acetaminophen	First cell therapy
	Fever	Grade 1	No treatment	Second cell therapy
	Left knee joint arthritis	Grade 2	Aspiration of fluid	Accidental symptom
	COVID-19 infection	Grade 2	Molnupiravir	COVID-19 epidemic

CTCAE: Common Terminology Criteria for Adverse Events; G-CSF: Granulocyte colony-stimulating factor; COVID-19: Coronavirus disease 2019.