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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Stem+Cells+Transl+Med
2017 ; 6
(3
): 689-699
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Administration of Adult Human Bone Marrow-Derived, Cultured, Pooled, Allogeneic
Mesenchymal Stromal Cells in Critical Limb Ischemia Due to Buerger s Disease:
Phase II Study Report Suggests Clinical Efficacy
#MMPMID28297569
Gupta PK
; Krishna M
; Chullikana A
; Desai S
; Murugesan R
; Dutta S
; Sarkar U
; Raju R
; Dhar A
; Parakh R
; Jeyaseelan L
; Viswanathan P
; Vellotare PK
; Seetharam RN
; Thej C
; Rengasamy M
; Balasubramanian S
; Majumdar AS
Stem Cells Transl Med
2017[Mar]; 6
(3
): 689-699
PMID28297569
show ga
Critical limb ischemia (CLI) due to Buerger's disease is a major unmet medical
need with a high incidence of morbidity. This phase II, prospective,
nonrandomized, open-label, multicentric, dose-ranging study was conducted to
assess the efficacy and safety of i.m. injection of adult human bone
marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (BMMSC) in
CLI due to Buerger's disease. Patients were allocated to three groups: 1 and 2
million cells/kg body weight (36 patients each) and standard of care (SOC) (18
patients). BMMSCs were administered as 40-60 injections in the calf muscle and
locally, around the ulcer. Most patients were young (age range, 38-42 years) and
ex-smokers, and all patients had at least one ulcer. Both the primary
endpoints-reduction in rest pain (0.3 units per month [SE, 0.13]) and healing of
ulcers (11% decrease in size per month [SE, 0.05])-were significantly better in
the group receiving 2 million cells/kg body weight than in the SOC arm.
Improvement in secondary endpoints, such as ankle brachial pressure index (0.03
[SE, 0.01] unit increase per month) and total walking distance (1.03 [SE, 0.02]
times higher per month), were also significant in the group receiving 2 million
cells/kg as compared with the SOC arm. Adverse events reported were remotely
related or unrelated to BMMSCs. In conclusion, i.m. administration of BMMSC at a
dose of 2 million cells/kg showed clinical benefit and may be the best regimen in
patients with CLI due to Buerger's disease. However, further randomized
controlled trials are required to confirm the most appropriate dose. Stem Cells
Translational Medicine 2017;6:689-699.