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Intramuscular or combined intramuscular/intra-arterial administration of bone marrow mononuclear cells in patients with advanced limb ischemia.


- candidate number2628
- NTR NumberNTR997
- ISRCTNISRCTN76049483
- Date ISRCTN created16-jul-2007
- date ISRCTN requested9-jul-2007
- Date Registered NTR13-jun-2007
- Secondary IDs 
- Public TitleIntramuscular or combined intramuscular/intra-arterial administration of bone marrow mononuclear cells in patients with advanced limb ischemia.
- Scientific TitleIntramuscular or combined intramuscular/intra-arterial administration of bone marrow mononuclear cells in patients with advanced limb ischemia.
- ACRONYMN/A
- hypothesisThe primary aim of our study was to test the feasibility and safety of exclusively intramuscular, and combined intramuscular/intra-arterial delivery of Bone marrow Mononuclear Cells (BMC) in patients with advanced without conventional options for surgical or endovascular treatment.
- Healt Condition(s) or Problem(s) studiedLimb ischemia, Stem cells, Bone marrow cells, Arteriogenesis
- Inclusion criteria1. Disabling claudication (Fontaine’s stages IIb/III or Rutherford’s categories 3/4) or critical limb ischemia (Fontaine’s stages IV or Rutherford’s categories 5/6) despite > 6 months optimal medical therapy;
2. Ineligibility for angioplasty or bypass procedures;
3. Male of female, >18 years old;
4. Life expectancy > 1 year;
5. Written informed consent.
- Exclusion criteria1. Candidates for angioplasty or bypass procedures;
2. Inability to undergo bone marrow harvesting;
3. Life threatening co-morbidity;
4. INR >2;
5. History of malignant disease in 5 years prior to treatment;
6. Inability to undergo arterial catheterization;
7. Inability to follow the protocol and to comply with the follow up requirements;
8. Any other conditions that, in the opinion of the investigators, could interfere with the therapy or could pose a significant threat to the subject if the investigational therapy was to be initiated.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-jan-2006
- Target number of participants25
- InterventionsHospital admittance was planned in a short-stay setting (24-48 hrs). The harvest procedure was performed according to standard protocols for bone marrow donation for allogenic transplantation. 750 milliliter bone marrow was collected from the posterior iliac crest under epidural or general anesthesia. The suspension was filtered and subsequently concentrated in a final volume of 40 mL. Upon concentration of the BMC-fraction, the erythrocyte fraction was collected separately and reinfused to the patient.
The mononuclear cells were implanted approximately 4 h after bone marrow aspiration. The method of administration was randomly assigned to the patients using a random number table: either by local injection into the gastrocnemius muscle or by combined IM+IA delivery. The investigators were not blinded for the assignment. In case of total IM delivery, we implanted 1 ml using a 26-gauge needle on 40 sites, 1.5 cm deep, using the full surface of the gastrocnemius muscle. In patients assigned to the combined treatment arm, the volume of each IM injection was 0.5 ml. The remaining 20 ml was slowly infused after selective catheterization of the superficial femoral artery (or profunda femoral artery in case of occlusion of the SFA), performed according to the standard procedures within the department of radiology.
- Primary outcome1. Wound healing / limb salvage (Fontaine 3/4);
2. Painfree walking distance (Fontaine 2).
- Secondary outcome1. Ankle/brachial index;
2. Brief Pain Inventory.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD, PhD Jan H. Lindeman
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan H. Lindeman
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Vascular Surgery
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Vascular Surgery
- PublicationsJ Cardiovasc Surg (Torino). 2008 Feb;49(1):51-8.
- Brief summaryA substantial number of patients with severe peripheral arterial occlusive disease (PAOD) is left without technical options for surgical or endovascular treatment. Recent evidence suggests that bone marrow mononuclear cells (BMC) may promote collateral vessel formation in these patients. However, several critical aspects such as long-term safety, effect durability, and optimal administration mode require consideration. We evaluated feasibility and safety of exclusively intramuscular versus combined intramuscular/intra-arterial delivery of BMC in patients with severe PAOD who were not candidates for surgical or endovascular treatment.
- Main changes (audit trail)
- RECORD13-jun-2007 - 29-okt-2008


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