Table 2.

Overview of the outcome parameters and results of clinical studies performed using BM-MNC in CLTI patients.

Reference	Cells	Injection site	Patients treated	Diabetic patients	Primary Outcome	Secondary Outcome	Endpoints met	Study design
Lindeman et al. (42)	BM-MNC	IM	28 BM-MNC; 26 placebo	None	Limb salvage, pain-free walking distance	ABI, QoL, pain	None	RCDBP-C
Malyar et al. (46)	BM-MNC	IA + IM	16 BM-MNC	50%	ABI, TcPO2	Pain-free walking distance	14/16 limb salvage after 6 months	NRNBNP-C
Pignon et al. (44)	BM-MNC	IM	17 BM-MNC; 19 placebo	55% of BM-MNC; 35% of placebo	Major amputation, death	Pain, ulcers, ABI, TcPO2	Decreased risk of major amputation	RDBP-C
Sharma et al. (45)	BM-MNC	IA	27 BM-MNC; 29 placebo	30% of BM-MNC; 28% of placebo	ABI, TcPO2	Rest pain, ulcer size, major amputation	Improved ABI, improved TcPO2	RDBP-C
Tateishi et al. (35)	BM-MNC and PB-MNC	IM	22 patients; 1 leg BM-MNC; 1 leg PB-MNC	69%	ABI, rest pain	TcpO2; pain-free walking time DSA	ABI, TcpO2, rest pain, pain-free walking time	DB
Teraa et al. (41)	BM-MNC	IA	81 BM-MNC; 79 placebo	36% of BM-MNC; 39% of placebo	Major amputation <6 months	Mortality, minor amputations, ulcer size, rest pain, pain-free walking distance, ABI, TcpO2, QOL	None	RDBP-C
Walter et al. (43)	BM-MNC	IA	19 BM-MNC; 21 placebo	53% of BM-MNC; 48% of placebo	ABI	Ulcer healing, amputation-free survival, mortality, rest pain	Ulcer area decreased, decreased pain	RDBP-C

ABI, ankle brachial index; DB, double-blind; DSA, digital subtraction angiography; IA, intra-arterial; IM, intramuscular; NRNBNP-C, not randomized, not blinded, not placebo-controlled; QOL, quality of life; RCDBP-C, randomized controlled, double-blind, placebo-controlled; RDBP-C, randomized, double-blind, placebo-controlled; TBI, toe brachial index; TcpO₂, transcutaneous oxygen pressure.