Emerging roles of mesenchymal stem cell therapy in patients with critical limb ischemia

Shirbaghaee, Zeinab; Hassani, Mohammad; Heidari Keshel, Saeed; Soleimani, Masoud

doi:10.1186/s13287-022-03148-9

Stem Cell Research & Therapy

Table 3 Classification of most important MSC therapy clinical trials for CLI

From: Emerging roles of mesenchymal stem cell therapy in patients with critical limb ischemia

NO	Trial ID	Phase/study condition	MSC source	Disease stage	Administration	Administration route	Endpoints	Follow-up (month)	Patient enrollment
1	NCT00468000	II/completed	Ixmyelocel-T (BM-MNCs and BM-MSCs)	NA	35 × 10⁶, 295 × 10⁶	IM	AFS, ABI, tcpO₂, AR, UH, VAS	12	72 (48/24)
2	NCT00518401	I/completed	MESENDO (BM-MNCs and BM-MSCs)	NA	20 × 10⁶, 40 × 10⁶	IM	AEs	6	10
3	NCT00721006	II/completed	MESENDO (BM-MNCs and BM-MSCs)	Rutherford 4–6	9 × 10⁶, 18 × 10⁶	IM	PWD, ABI	4	26
4	NCT00883870	I/II/completed	Stempeucel(R) (allogenic BM-MSCs)	Rutherford 4–6	200 × 10⁶	IM	AEs, ABI, AR, NRS, UH	6	20 (10/10)
5	NCT00955669	I/completed	BM-MSCs or MNCs	Fontaine 5	9.3 ± 1.1 × 10⁸ BM, MSC/9.6 ± 1.1 × 10⁸ MNC	IM	AEs, UH, PWD, ABI, tcpO₂, ASM	6	40
6	NCT01065337	II/completed	BM-MNCs and BM-MSCs	Fontaine 3–5	200 × 10⁶, 300 × 10⁶	IM	ABI, TcPO₂, UH, ILP	12	30
7	NCT01351610	I/II/completed	MSC_Apceth (BM-MSCs)	Rutherford ≥ 4	NA	IA	AEs, VAS	12	25
8	NCT01484574	II/completed	Stempeucel(R) (allogenic BM-MSCs)	Rutherford 3–5	NA	IM	UH, NRS, PWD, AFS, ABI, tcpO_2, RA	24	90
9	NCT01456819	II/unknown	BM-MNCs or BM-MSCs	NA	NA	IM	UH, VAS, DSA, ETT	12	50
10	NCT01483898	III/completed	Ixmyelocel-T (BM-MNCs and BM-MSCs)	Rutherford 5	35 × 10⁶, 295 × 10⁶	IM	AFS, UH, MACE	18	41
11	NCT02336646	I/completed	BM-MSCs	Rutherford 4–6	NA	IM	AEs, ABI, tcpO₂, WBFRS, TWD	6	18
12	NCT02685098	I/II/recruiting	BM-MSCs	Rutherford 2–4	NA	IM	AEs, TcPO₂, ABI, ICA	24	16
13	NCT03042572	II, III/N/A	BM-MSCs	Rutherford class 4–5	150 × 10⁶	IM	VAS, ABI, TBI, PWD, UH	6	66
14	NCT03455335	I_b/completed	BM-MSCs	Rutherford 4, 5	20 × 10⁶, 40 × 10⁶	IM	AEs, AR, ABI, TcPO₂, NRS, UH	12	12
15	TRI/2018/02/011839	IV/completed	Stempeucel(R) (allogenic BM-MSCs)	Rutherford 5–6	2 × 10⁶ cells/kg	IM	AEs, ABI, UH, VAS	12	50
16	NCT01257776	I, II/completed	Ad-MSCs or MNCs	Rutherford 2–4	0.5 × 10⁶, 1 × 10⁶ kg/ml	IA	AEs, UH, tcpO₂, and ABI	12	36
17	NCT01211028	I, II/completed	Ad-MSCs	Rutherford 2–6	100 × 10⁶	IM	AEs, UH, NRS, VAS, tcpO₂, ABI	6	13
18	NCT01302015	NA/completed	RNL-Vascostem^® (Ad-MSCs)	Rutherford 4–6	300 × 10⁶	IM	AEs, UH, ABI, ETT, DSA, AR, WBFRS	6	15
19	NCT01745744	II/completed	Ad-MSCs	Rutherford 2–4	0.5 × 10⁶, 1 × 10⁶ cell/kg	IA	AEs, ABI, tcpO_2, ulcer size, MWD,	12	33
20	NCT01663376	NA/completed	Ad-MSCs	Rutherford 4–6	100 × 10⁶, 300 × 10⁶	IM	AEs, ABI, DSA, thermography, WBFRS, ETT	12	20
21	NCT01824069	I_b/completed	Ad-MSCs	Rutherford 4–5	1 × 10⁶ cells/kg	IM	AEs, ABI, AR, ILP	12	7
22	NCT02145897	I, II/unknown	Ad-MSCs	Rutherford 4–5	1 × 10⁶ cells/kg	IM/IV	AEs, ABI, tcpO₂, UH	9	60
23	NCT03968198	II/recruiting	Ad-MSCs	NA	90 × 10⁶	IM	AFS, ABI, tcpO₂, UH	6	43
24	NCT04466007	II/recruiting	Ad-MSCs	Rutherford 4–5	1 × 10⁶ cells/Kg, 2 × 10⁶ cells/Kg	IM	AEs, vascularization, Rutherford–Becker scale, ABI, AR	12	90
25	NCT04661644	I, II_a/recruiting	Ad-MSCs	Rutherford 4–6	1 × 10⁷ cells/1 mL/via, 1 × 10⁸ cells/1 mL/vial	IM	VAS, PWD, ABI, TBI, UH, MTD	6	20
26	NCT04746599	NA/recruiting	Ad-MSCs	NA	NA	IA	NRS, ABI, tcpO₂, AFS	6	20
27	NCT05475418	NA/not yet recruiting	Adipose tissue-derived exosomes mixed with hydrogel	Texas grade 1A–D, 2A–D	NA	Wound surface	UH	1	5
28	NCT01558908	I, II/unknown	ERC	Rutherford 4–5	25 × 10⁶, 50 × 10⁶, 100 × 10⁶	IM	AEs, ABI, VAS, UH, tcpO₂	13	15
29	NCT03267784	I, IIa/completed	ABCB5-positive MSCs	Wagner 1–2	2 × 10⁶/cm² wound surface area	Wound surface	AEs, ABI, UH, NRS, AR	12	23
30	NCT01216865	I, II/unknown	UCB-MSCs	NA	50 × 10⁶	IM	Angiogenesis, ABI, UH, PWD, AR	6	50
31	NCT03994666	II/unknown	UCB-MSCs	NA	60 × 10⁶, 120 × 10⁶	IM	AEs, ABI, tcpO₂, DR	12	30
32	NCT03423732	II, III/active, not recruiting	CardioCell (WJ-MSC)	Rutherford 4–5	30 × 10⁶	IM, IA	ABI, tcpO₂, AFS, UFS	12	50
33	NCT01859117	I/completed	Cenplacel (PDA-002) (P-MSCs)	Wagner 1–2	3 × 10⁶ 10 × 10⁶ 30 × 10⁶ 100 × 10⁶	IM	AEs, UH, ABI, TBI	24	15
34	NCT00919958	I/completed	PLX-PAD (P-MSCs)	Rutherford 4–5	175 × 10⁶, 315 × 10⁶, 595 × 10⁶	IM	AEs, IR tumorigenesis, AS	24	15
35	NCT00951210	I/completed	PLX-PAD (P-MSCs)	Rutherford 4–5	280 × 10⁶	IM	AEs, DR, AR, IR, VAS	6	12
36	NCT01679990	II/completed	PLX-PAD (P-MSCs)	Rutherford 2–4	NA	IM	MWD	12	180
37	NCT03006770	III/active, not recruiting	PLX-PAD (P-MSCs)	Rutherford 5	300 × 10⁶	IM	MA, DR, NRS, UH	36	213
38	ChiCTR-ONC-16008732	I/completed	P-MSCs	NA	1 × 10⁶ cells/kg	IM	AEs, PWD, MRA, ABI, UH, AR	6	4
39	IRCT20210221050446N1	I, II_a/active	P-MSCs	Rutherford 4–6	20 × 10⁶, 30 × 10⁶, 60 × 10⁶	IM	AR, AEs, ABI, DSA, IR, UH, MTD, PWD, NRS	6	9

ABI ankle-brachial index, AEs adverse events, AFS amputation-free survival, AR amputation rate, ASM angiographic score of MRA, DR death rate, DSA digital subtraction angiography, ETT exercise treadmill test, IA intra-arterial, ICA indocyanine angiography angiogram, ILP improvement of local perfusion transluminal angioplasty, IM intramuscular, IR immunological reaction, IV intravenous, MACE major adverse cardiac event, MRA magnetic resonance angiography, MTD maximum tolerable dose, MWD maximal walking distance, NA not applicable, NRS numeric rating scale, PWD pain-free walking distance, ERC endometrial regenerative cell (menstrual mesenchymal stem cells), TBI toe-brachial index, TcPO₂ transcutaneous oxygen pressure, TWD total walking distance, UFS ulcer-free survival, UH ulcer healing, VAS visual analog scale, WBFRS Wong–Baker FACES pain rating score, WJ-MSC Wharton’s jelly mesenchymal stem cell

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