Primary Endpoint



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tarix30.10.2018
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Primary Endpoint

  • Primary Endpoint

    • Change in ankle-brachial index (ABI) at 3 and 6 months
  • Secondary Endpoint

    • Wound healing
    • Pain reduction
    • Amputation-free survival


Patients with Fontaine III or IV

  • Patients with Fontaine III or IV

  • who were not candidates for interventional or surgical revascularization or who failed to respond to interventional or surgical procedures.

  • PAOD or thrombangitis obliterans (TAO)

  • Exclusion: prior PTA or Bypass < 3 months

  • Creatinine > 2.0 mg/dl at time ot treatment







Ankle-brachial index (1ry EP) in 26 patients with complete serial measurements

  • Ankle-brachial index (1ry EP) in 26 patients with complete serial measurements



Ankle-brachial index (1ry EP) in 26 patients with complete serial measurements

  • Ankle-brachial index (1ry EP) in 26 patients with complete serial measurements



ABI values were not useful as primary endpoint

  • ABI values were not useful as primary endpoint

  • Changes in ABI do not correlate well with ulcer healing and limb salvage

  • In patients with thrombangiitis obliterans (TAO) as well as in patients with extensive mediasclerosis, ABI values do not reflect the degree of distal ischemia and tissue necrosis.





















Intraarterial administration of BM-MNC significantly promotes ulcer healing and reduces rest pain until 3 months versus Placebo

  • Intraarterial administration of BM-MNC significantly promotes ulcer healing and reduces rest pain until 3 months versus Placebo

  • Successful ulcer healing associated with improved limb salvage requires repeated administration of functionally competent BM-MNC

  • Patients with thrombangiitis obliterans generally responded well, critically ill patients with extensive gangrene and impending amputation did not derive any benefit.



Thus, large scale randomized trials are warranted to assess the clinical effect of repeated BM-MNC administration in patients with critical limb ischemia with stable ulcers and/or rest pain.

  • Thus, large scale randomized trials are warranted to assess the clinical effect of repeated BM-MNC administration in patients with critical limb ischemia with stable ulcers and/or rest pain.

  • Complete ulcer healing occurred at a mean of 10.9 months after BM-MNC administration

  • To assess potential clinical benefits of cell therapy in patients with critical limb ischemia, a follow-up period of at least 18 months will be required.







Younger age

  • Younger age

  • Better ejection fraction

  • Smaller ulcer size (< 2.3 cm² , p =0.038)

  • Less rest pain at baseline

  • Better renal function (creatinine < 1.4 mg/dl)

  • TAO (all 8 TAO) responders versus 18 of 32 (56%) atherosclerotic PAOD improved clinically by BM-MNC treatments (P=0.02 TAO vs. PAOD).

  • Patients with gangrene (Rutherford 6) did not respond at all.







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