Biomedical Engineering Reference
In-Depth Information
mixture of inflammatory cells and cytokines in addition to the modest population
of SCs. In the case of SVF it also contains mature endothelial and HSCs, the latter
representing up to 20 % [
11
].
It is also important to wait for the final results of ongoing trials before con-
clusions are made. Several MSCs phase III (for graft versus host disease, Crohn's
and perianal fistula) have encountered some methodological difficulties (patients
receiving control treatment performed better than anticipated, necessity of sub-
group analysis, etc.) even though previous studies had shown beneficial effects.
Maybe the most important conclusion by now is that the treatments have been safe,
almost no serious adverse events related to therapy have been reported and that the
protocol is minimally-invasive and the risk of affecting continence is insignificant.
12.8.3 Ulcerative Colitis
12.8.3.1 Relevant Published Studies
There are two from the same group. In the first one, allogeneic BM-MSCs were
tested and remission duration increased and relapsing risk and hospital admissions
were reduced compared with medication (5-aminosalicylic acid and glucocorti-
costeroid) [
110
]. The second one studies allogeneic intravenous BM-MSCs effi-
cacy and safety during 2 years. Authors studied 40 patients who had not received
biological drugs and 12 who underwent infliximab; 44 of them received BM-
MSCs. A statistically significant (compared with conventional treatment) reduc-
tion in clinical and morphological inflammatory scores was found in 34 (72.7 %)
patients whereas no therapeutic effect was reached on 12. MSCs allowed canceling
corticosteroids in most patients with hormone-dependent and steroid resistant
forms and in seven to reduce prednisolone to 5 mg/day. They also concluded
than
remission
duration
increased
and
recurrence
risk
and
hospitalizations
reduced [
111
].
12.8.3.2 Registered Clinical Trials
In June 2011, there were two (Tables
12.2
and
12.3
).
NCT01221428 is a phase I/II single group safety and efficacy study about
intravenous (2 9 10
7
SCs) and posteriorly mesenteric artery (1 9 10
7
) adminis-
tration of umbilical cord allogeneic MSCs for refractory disease. The follow-up is
three months and authors study endoscopic, pathological, and clinical response.
NCT01240915 is a randomized, placebo controlled, and multicenter phase II
study on safety and efficacy of Multistem
(PF-05285401) in moderate to severe
refractory disease. Multistem
is obtained from bone marrow and other non-
embryonic tissues and composed by healthy donors allogeneic MAPCs [
112
].
Placebo and different dosages and temporary administration protocols will be
