Autologous bone marrow-derived mononuclear cells for therapeutic arteriogenesis in patients with limb ischemia A double blind placebo controlled study in diabetic and non-diabetic patients
Phase 3
- Conditions
- claudication10003216
- Registration Number
- NL-OMON37216
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients with persistent (>3 months, despite optimal treatment) disabling claudication or with critical leg ischemia (Fontaine's stages IIb-IV or Rutherford's categories 3-6) without adequate options for improvements by PTA or reconstructive surgery will be included in the study.
Exclusion Criteria
candidates for angioplasty or bypass procedures
-inability to undergo bone marrow harvesting
-any condition in the affected limb that is anticipated to require surgical intervention in the first weeks after BM-MNC treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints are pain free walking distance (Fontaine IIb/III), and limb<br /><br>salvage/wound healing (Fontaine IV) at t=6 months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include quality of life (RAND-36), walking impairment<br /><br>score, pain scores, ABI at t=3, 6 and 12 months, Limb salvage/wound healing at<br /><br>t=12 months as well as pain free walking distance at t=3 and 12 months. Upon<br /><br>reaching the primary endpoint (t=6 months), the study will commence as an open<br /><br>study. Patients in the placebo arm will be offered their frozen bone marrow.<br /><br>Results of this intervention will be analyzed separately.</p><br>