Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia

Claudio Napoli, Bartolomeo Farzati, Vincenzo Sica, Emanuele Iannuzzi, Giuseppe Coppola, Andrea Silvestroni, Maria Luisa Balestrieri, Anna Florio, Angelo Matarazzo

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

Background: Short-term (within 6 weeks follow-up) clinical studies indicate that implantation of bone marrow cells (BMCs) into ischemic limbs may improve peripheral ischemia. Here, the long-term safety and feasibility of intraarterial autologous BMCs with oral treatment with antioxidants and L-arginine were investigated in patients with critical ischemia on account of advanced atherosclerotic peripheral arterial disease (PAD). Methods: Eighteen patients with PAD (advanced III/IV Fontaine stages) were enrolled in this study (NCT00306085). An additional group of 18 patients taking maximal drug therapy that refused BMC therapy served as control. The BMC-treated group received two doses of BMCs in the leg arteries (time 0 and 45 days). After 30 days from the first BMC dose, patients received daily antioxidants, and L-arginine. Therapeutic neoangiogenesis was estimated by angiography and laser Doppler\capillaroscopy. Results: Ankle brachial index improvement (ΔABI: >0.1) was seen in 10 patients at 3 months and in 12 patients at 12-18 months. Ischemic ulcers improved in 13 patients (after 6-12 months). Although two patients underwent amputation, the mean maximum walking distance significantly increased at 3 months and was sustained up to 18 months. Among conservative patients, 10 underwent amputation in comparison with two BMC-treated patients (55.6 vs. 13.3%; P=0.014). Conclusion: This small study shows that intraarterial autologous BMC and antioxidants and L-arginine therapy is safe and effective in patients with advanced atherosclerotic PAD with positive effects until 18 months.

Original languageEnglish
Pages (from-to)709-718
Number of pages10
JournalEuropean Journal of Cardiovascular Prevention and Rehabilitation
Volume15
Issue number6
DOIs
Publication statusPublished - Dec 2008

Fingerprint

Bone Marrow Cells
Arginine
Ischemia
Extremities
Antioxidants
Peripheral Arterial Disease
Amputation
Microscopic Angioscopy
Ankle Brachial Index
Cell- and Tissue-Based Therapy
Ulcer
Walking
Leg
Angiography
Lasers
Therapeutics
Arteries
Safety
Drug Therapy

Keywords

  • Antioxidants
  • Bone marrow cells
  • L-arginine
  • Peripheral arterial disease

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Epidemiology
  • Medicine(all)

Cite this

Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. / Napoli, Claudio; Farzati, Bartolomeo; Sica, Vincenzo; Iannuzzi, Emanuele; Coppola, Giuseppe; Silvestroni, Andrea; Balestrieri, Maria Luisa; Florio, Anna; Matarazzo, Angelo.

In: European Journal of Cardiovascular Prevention and Rehabilitation, Vol. 15, No. 6, 12.2008, p. 709-718.

Research output: Contribution to journalArticle

Napoli, Claudio ; Farzati, Bartolomeo ; Sica, Vincenzo ; Iannuzzi, Emanuele ; Coppola, Giuseppe ; Silvestroni, Andrea ; Balestrieri, Maria Luisa ; Florio, Anna ; Matarazzo, Angelo. / Beneficial effects of autologous bone marrow cell infusion and antioxidants/L-arginine in patients with chronic critical limb ischemia. In: European Journal of Cardiovascular Prevention and Rehabilitation. 2008 ; Vol. 15, No. 6. pp. 709-718.
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AU - Napoli, Claudio

AU - Farzati, Bartolomeo

AU - Sica, Vincenzo

AU - Iannuzzi, Emanuele

AU - Coppola, Giuseppe

AU - Silvestroni, Andrea

AU - Balestrieri, Maria Luisa

AU - Florio, Anna

AU - Matarazzo, Angelo

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N2 - Background: Short-term (within 6 weeks follow-up) clinical studies indicate that implantation of bone marrow cells (BMCs) into ischemic limbs may improve peripheral ischemia. Here, the long-term safety and feasibility of intraarterial autologous BMCs with oral treatment with antioxidants and L-arginine were investigated in patients with critical ischemia on account of advanced atherosclerotic peripheral arterial disease (PAD). Methods: Eighteen patients with PAD (advanced III/IV Fontaine stages) were enrolled in this study (NCT00306085). An additional group of 18 patients taking maximal drug therapy that refused BMC therapy served as control. The BMC-treated group received two doses of BMCs in the leg arteries (time 0 and 45 days). After 30 days from the first BMC dose, patients received daily antioxidants, and L-arginine. Therapeutic neoangiogenesis was estimated by angiography and laser Doppler\capillaroscopy. Results: Ankle brachial index improvement (ΔABI: >0.1) was seen in 10 patients at 3 months and in 12 patients at 12-18 months. Ischemic ulcers improved in 13 patients (after 6-12 months). Although two patients underwent amputation, the mean maximum walking distance significantly increased at 3 months and was sustained up to 18 months. Among conservative patients, 10 underwent amputation in comparison with two BMC-treated patients (55.6 vs. 13.3%; P=0.014). Conclusion: This small study shows that intraarterial autologous BMC and antioxidants and L-arginine therapy is safe and effective in patients with advanced atherosclerotic PAD with positive effects until 18 months.

AB - Background: Short-term (within 6 weeks follow-up) clinical studies indicate that implantation of bone marrow cells (BMCs) into ischemic limbs may improve peripheral ischemia. Here, the long-term safety and feasibility of intraarterial autologous BMCs with oral treatment with antioxidants and L-arginine were investigated in patients with critical ischemia on account of advanced atherosclerotic peripheral arterial disease (PAD). Methods: Eighteen patients with PAD (advanced III/IV Fontaine stages) were enrolled in this study (NCT00306085). An additional group of 18 patients taking maximal drug therapy that refused BMC therapy served as control. The BMC-treated group received two doses of BMCs in the leg arteries (time 0 and 45 days). After 30 days from the first BMC dose, patients received daily antioxidants, and L-arginine. Therapeutic neoangiogenesis was estimated by angiography and laser Doppler\capillaroscopy. Results: Ankle brachial index improvement (ΔABI: >0.1) was seen in 10 patients at 3 months and in 12 patients at 12-18 months. Ischemic ulcers improved in 13 patients (after 6-12 months). Although two patients underwent amputation, the mean maximum walking distance significantly increased at 3 months and was sustained up to 18 months. Among conservative patients, 10 underwent amputation in comparison with two BMC-treated patients (55.6 vs. 13.3%; P=0.014). Conclusion: This small study shows that intraarterial autologous BMC and antioxidants and L-arginine therapy is safe and effective in patients with advanced atherosclerotic PAD with positive effects until 18 months.

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