Rejuvenating Endothelial Progenitor Cells Via Transcutaneous Intra-Arterial Supplementation | Clinical Trial - JUVENTAS

Jan 14, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Stichting Vrienden UMC Utrecht, The Netherlands; Organization for Scientific Research, Stichting De Drie Lichten
Date Published:
01/14/2015
Original Posted Date:
01/14/2015
References

Description:

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.

Study Design

  • Placebo
  • Randomized
  • Blinded
  • Parallel

Patient Population:

  • Participants with non-revascularizable limb ischemia
  • Number of enrollees: 160
  • Duration of follow-up: 6 months
  • Mean patient age: 69 years
  • Percentage female: 30%

Primary Endpoint:

  • Major amputations at 6 months

Drugs/Procedures Used:

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).

Principal Findings:

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

Interpretation:

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.

References:

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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