Cardiovascular Diseases Clinical Trial
Official title:
Allogeneic Mesenchymal Stromal Cells for Angiogenesis and Neovascularization in No-option Ischemic Limbs; A Double-blind, Randomized, Placebo-controlled Trial
The primary objective of this trial is to investigate whether intramuscular administration of
allogeneic mesenchymal stromal cells (MSC) is safe and potentially effective, assessed as a
composite outcome of mortality, limb status, clinical status (Rutherford classification) and
pain score (visual analogue scale), in patients with no-option severe limb ischemia (SLI).
The investigators will conduct a double-blind, placebo-controlled randomized clinical trial
to investigate the effect of allogeneic bone marrow(BM)-derived MSC in patients with SLI, who
are not eligible for conventional surgical or endovascular therapies. The investigators
intend to include 60 patients, who will be randomized to undergo 30 intramuscular injections
with either BM-MSC (30 injection sites with 5*10^6 MSCs each) or placebo in the lower leg of
the ischemic extremity. Primary outcome i.e. therapy success, a composite outcome considering
mortality, limb status, clinical status (Rutherford classification) and changes in pain
score, will be assessed at six months.
n/a
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