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DOI: 10.1055/s-0031-1274561
© Georg Thieme Verlag KG Stuttgart · New York
Therapeutische Angiogenese mittels Gen- und Stammzellentherapie bei der peripheren arteriellen Verschlusskrankheit
Therapeutic angiogenesis using gene transfer and stem cell therapy in peripheral artery diseasePublikationsverlauf
Publikationsdatum:
29. März 2011 (online)

Zusammenfassung
Die bisher weltweit größte Angiogenese-Gentherapie-Studie mit 525 Patienten mit kritischer Beinischämie, die mit dem nicht viralen Gen für den Fibroblasten-Wachstumsfaktor 1 (NV1FGF) oder Plazebo behandelt wurden, war bezüglich aller Endpunkte negativ. Aber auch bezüglich einer Stammzellen- bzw. Progenitorzell-Therapie für die periphere arterielle Verschlusskrankheit gibt es augenblicklich noch keine gesicherten Daten, die einen klinischen Benefit belegen. Daten aus großen randomisierten placebokontrollierten Studien stehen noch aus.
Abstract
The world-wide largest angiogenesis gene therapy trial in 525 patients suffering from critical limb ischemia and treated with the non-viral gene construct for fibroblast growth factor (NV1FGF) or placebo was negative for all endpoints. Also, stem cell or progenitor cell therapy did no reveal clinical benefit in patients with peripheral artery disease. Data from large randomized placebo-controlled are still not available.
Schlüsselwörter
Angiogenese - Stammzelltherapie - periphere arterielle Verschlusskrankheit
Keywords
angiogenesis - stem cell therapy - peripheral artery disease
Literatur
- 1
Asahara T, Murohara T, Sullivan A, Silver M, van der Zee R, Li T, Witzenbichler B, Schatteman G, Isner J M.
Isolation of putative progenitor endothelial cells for angiogenesis.
Science.
1997;
275
964-967
MissingFormLabel
- 2 Creager M, Olin J W, Belch J. et al .A randomized, double-blind, placebo-controlled,
parallel group study of ad2/hypoxia inducible factor (HIF-1a/vp16)
in patients with intermittent claudication. Orlando, Florida: American College of Cardiology (ACC) 58th Annual Scientific
Session; March 29 – 31, 2009
MissingFormLabel
- 3
Isner J M, Pieczek A, Schainfeld R, Blair R, Haley L, Asahara T, Rosenfield K, Razvi S, Walsh K, Symes J F.
Clinical evidence
of angiogenesis after arterial gene transfer of phVEGF165 in patient
with ischaemic limb.
Lancet.
1996;
348
370-374
MissingFormLabel
- 4
Kusumanto Y H, van Weel V, Mulder N H, Smit A J, van den Dungen J J, Hooymans J M, Sluiter W J, Tio R A, Quax P H, Gans R O, Dullaart R P, Hospers G A.
Treatment
with intramuscular vascular endothelial growth factor gene compared
with placebo for patients with diabetes mellitus and critical limb
ischemia: a double-blind randomized trial.
Hum Gene Ther.
2006;
17
683-691
MissingFormLabel
- 5
Lawall H, Bramlage P, Amann B.
Stem cell and progenitor cell therapy in peripheral artery disease.
A critical appraisal.
Thromb Haemost.
2010;
103
696-709
MissingFormLabel
- 6
Makinen K, Manninen H, Hedman M, Matsi P, Mussalo H, Alhava E, Yla-Herttuala S.
Increased vascularity detected by digital subtraction angiography
after VEGF gene transfer to human lower limb artery: a randomized,
placebo-controlled, double-blinded phase II study.
Mol
Ther.
2002;
2
127-133
MissingFormLabel
- 7
Nikol S, Baumgartner I, Van Belle E, Diehm C, Visoná A, Capogrossi M C, Ferreira-Maldent N, Gallino A, Wyatt M G, Wijesinghe L D, Fusari M, Stephan D, Emmerich J, Pompilio G, Vermassen F, Pham E, Grek V, Coleman M, Meyer F TALISMAN 201 investigators.
Therapeutic angiogenesis with intramuscular NV1FGF improves
amputation-free survival in patients with critical limb ischemia.
Mol Ther.
2008;
16
972-978
MissingFormLabel
- 8
Powell R J, Goodney P, Mendelsohn F O, Moen E K, Annex B H. HGF-0205 Trial Investigators .
Safety and efficacy of patient specific intramuscular injection
of HGF plasmid gene therapy on limb perfusion and wound healing
in patients with ischemic lower extremity ulceration: results of
the HGF- 0205 trial.
J Vasc Surg.
2010;
52
1525-1530
MissingFormLabel
- 9
Rajagopalan S, Mohler 3rd E R, Lederman R J, Mendelsohn F O, Saucedo J F, Goldman C K, Blebea J, Macko J, Kessler P D, Rasmussen H S, Annex B H.
Regional
angiogenesis with vascular endothelial growth factor in peripheral
arterial disease: a phase II randomized, double-blind, controlled
study of adenoviral delivery of vascular endothelial growth factor
121 in patients with disabling intermittent claudication.
Circulation.
2003;
108
1933-1938
MissingFormLabel
- 10
Sprengers R W, Moll F L, Verhaar M C.
Stem cell therapy in PAD.
Eur
J Vasc Endovasc Surg.
2010;
39 Suppl
1
S38-43
MissingFormLabel
- 11
Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T. Therapeutic Angiogenesis using Cell Transplantation (TACT)
Study Investigators .
Therapeutic angiogenesis for patients
with limb ischaemia by autologous transplantation of bone-marrow
cells: a pilot study and a randomised controlled trial.
Lancet.
2002;
360
427-435
MissingFormLabel
- 12 US National Institutes
of Health .A Phase 2, randomized, double-blind, placebo-controlled,
parallel-group, multicenter, dose-selection study of Ad2/Hypoxia
Inducible Factor (HIF)-1α/VP16 in patients with
intermittent claudication. http://clinicaltrials.gov/ ct2/show/NCT00117650?term= WALK+HIF-1+alpha&rank=1 (letzter Zugriff 3.3.2011)
MissingFormLabel
- 13 Walter D. PROVASA-Studie, Präsentation im Rahmen des Leipzig
Interventional Course- LINC- 2010.
MissingFormLabel
- 14 Hiatt W R, Baumgartner I, Nikol S, Van Belle E, Driver V, Norgren L, Belch J. (TAMARIS steering committee) .http://www.slideshare.net/alizotte/aha-tamaris (letzter Zugriff 3.3.2011)
MissingFormLabel
Prof. Dr. med. Sigrid Nikol
Chefärztin Klinische und Interventionelle
Angiologie
Asklepios Klinik St.Georg
Lohmühlenstr.
5
20099 Hamburg
Telefon: 040-1818852401
Fax: 040-1818853980
eMail: s.nikol@asklepios.com