Rejuvenating Endothelial Progenitor Cells Via Transcutaneous Intra-Arterial Supplementation | Clinical Trial - JUVENTAS
The goal of the trial was to evaluate treatment with repeated intra-arterial infusion of bone marrow derived mononuclear cells compared with placebo among participants with non-revascularizable limb ischemia.
Hypothesis: Repeated intra-arterial infusion of bone marrow derived mononuclear cells will reduce major amputations at 6 months.
- Participants with non-revascularizable limb ischemia
- Number of enrollees: 160
- Duration of follow-up: 6 months
- Mean patient age: 69 years
- Percentage female: 30%
- Major amputations at 6 months
Participants with non-revascularizable limb ischemia were randomized to infusion of bone marrow derived mononuclear cells into the common femoral artery once per week for 3 weeks (n = 81) versus placebo injections with the same frequency (n = 79).
Overall, 160 patients were randomized. The mean age was 69 years, 30% were women, 22% had angioplasty of the contralateral leg, 14% had bypass of the contralateral leg, 6% had major amputation of the contralateral leg, 63% had Rutherford stage 5 or 6, 23% were current smokers, 36% had diabetes, and mean body mass index was 26.2 kg/m2.
At 6 months, the primary outcome of major amputations occurred in 19% of the bone marrow derived mononuclear cell group versus 13% of the placebo group (p = 0.31).
The primary safety outcome of all-cause mortality, malignancy, or hospitalization for infection occurred in 15% of the bone marrow derived mononuclear cell group versus 10% of the placebo group (p = NS).
- Death at 6 months: 5% vs. 6% (p = 0.74), respectively
- Major amputation or death at 6 months: 23% vs. 16% (p = 0.27), respectively
Among patients with non-revascularizable limb ischemia, repeated intra-arterial infusion of bone marrow derived mononuclear cells was not beneficial. This therapy did not reduce major amputations or a composite safety outcome of death, malignancy, or hospitalization for infection. To date, bone marrow derived stem cell therapy has not been able to demonstrate improvement in lower extremity perfusion.
Teraa M, Sprengers RW, Schutgens RE, et al. Effect of Repetitive Intra-Arterial Infusion of Bone Marrow Mononuclear Cells in Patients With No-Option Limb Ischemia: The Randomized, Double-Blind, Placebo-Controlled JUVENTAS Trial. Circulation 2015;Jan 7:[Epub ahead of print].
Keywords: Amputation, Angioplasty, Bone Marrow, Cell- and Tissue-Based Therapy, Diabetes Mellitus, Double-Blind Method, Femoral Artery, Hospitalization, Infusions, Intra-Arterial, Ischemia, Lower Extremity, Peripheral Vascular Diseases
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