Efficacy and safety of application «Neovasculgen» in the complex treatment patients with chronic lower limbischemia (IIb-III phase of clinical trials)
- Authors: Shvalb PG1, Gavrilenko AV2, Kalinin RE1, Chervyakov Y.V3, Voronov DA2, Staroverov IN3, Gryaznov SV1, Mzavanadze ND1, Nersesyan EG3, Kiselev SL4, Isaev AA4, Deev RV4
-
Affiliations:
- I.P. Pavlov Ryazan State Medical University, Ryazan
- B.V. Petrovsky Russian Scientific Center of Surgery, Moscow
- Yaroslavl State Medical Academy, Yaroslavl
- Human Stem Cells Institute, Moscow
- Issue: Vol 6, No 3 (2011)
- Pages: 76-83
- Section: Articles
- URL: https://genescells.ru/2313-1829/article/view/121558
- DOI: https://doi.org/10.23868/gc121558
- ID: 121558
Cite item
Open Access
Access granted
Subscription or Fee Access
Abstract
comparative follow-up of non-resectable patients with
lower limb atherosclerosis having clinical symptoms as
claudication (IIa-III stages according to the Fontaine-
Pokrovsky classification) who received Neovasculgen
as a part of conservative therapy. Neovasculgen, a gene
therapy drug, is a plasmid construction with a vascular
endothelial growth factor gene. 100 patients were enrolled
into the study: 75 patients comprised the clinical group,
while 25 ones being the controls. The patients underwent
treatment in three clinical centers. The drug was injected
intramuscular, maximally close to ischemia zones, twice in
doses of 1.2 mg with the interval of 14 days. The following
factors were controlled: pain free walking distance (PlWD),
ankle-brachial index (ABI), transcutaneous partial pressure
of oxygen (TcPO2), linear blood flow rate (LBFR) in the
involved segment, angiography; also the integral treatment
result on the scale «success/failure», quality of life SF-36
questionnaire were assessed. The study duration was 6
months. PlWD was determined to increase by 110% that
shows statistically significant difference versus the control
(P=0.000).
About the authors
P G Shvalb
I.P. Pavlov Ryazan State Medical University, RyazanI.P. Pavlov Ryazan State Medical University, Ryazan
A V Gavrilenko
B.V. Petrovsky Russian Scientific Center of Surgery, MoscowB.V. Petrovsky Russian Scientific Center of Surgery, Moscow
R E Kalinin
I.P. Pavlov Ryazan State Medical University, RyazanI.P. Pavlov Ryazan State Medical University, Ryazan
Yu V Chervyakov
Yaroslavl State Medical Academy, YaroslavlYaroslavl State Medical Academy, Yaroslavl
D A Voronov
B.V. Petrovsky Russian Scientific Center of Surgery, MoscowB.V. Petrovsky Russian Scientific Center of Surgery, Moscow
I N Staroverov
Yaroslavl State Medical Academy, YaroslavlYaroslavl State Medical Academy, Yaroslavl
S V Gryaznov
I.P. Pavlov Ryazan State Medical University, RyazanI.P. Pavlov Ryazan State Medical University, Ryazan
N D Mzavanadze
I.P. Pavlov Ryazan State Medical University, RyazanI.P. Pavlov Ryazan State Medical University, Ryazan
E G Nersesyan
Yaroslavl State Medical Academy, YaroslavlYaroslavl State Medical Academy, Yaroslavl
S L Kiselev
Human Stem Cells Institute, MoscowHuman Stem Cells Institute, Moscow
A A Isaev
Human Stem Cells Institute, MoscowHuman Stem Cells Institute, Moscow
R V Deev
Human Stem Cells Institute, MoscowHuman Stem Cells Institute, Moscow
References
- Национальные рекомендации по ведению пациентов с со- судистой артериальной патологией (Российский согласительный документ). Часть 1. Периферические артерии. 2010; М.: Изд-во НЦССХ им. А.Н. Бакулева РАМН.
- Клиническая ангиология: Руководство для врачей. Под ред. А.В. Покровского. 2004; 1: 808.
- Norgren L., Hiatt W.R., Dormandy J.A. et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur. J. Vasc. Endovasc. Surg. 2007; 33: S1-70.
- Деев Р.В., Григорян А.С., Потапов И.В. и др. Мировой опыт генотерапии ишемических заболеваний. Ангиология и сосудистая хирургия 2011; 17(2): 145-54.
- Швальб П.Г., Калинин Р.Е., Грязнов С.В. и др. Безопасность и краткосрочная эффективность генотерапевтического препарата у пациентов с хронической ишемией нижних конечностей. Кардиоло- гия и сердечно-сосудистая хирургия 2011; 4: 61-66.
- Gupta R., Tongers J., Losordo D.W. Human Studies of Angiogenic Gene Therapy. Circ. Res. 2009; 105: 724-36.
- Швальб П.Г., Калинин Р.Е., Грязнов С.В. и др. Результаты 1/2а фазы клинических испытаний генотерапевтического препарата для терапевтического ангиогенеза. Сердечно-сосудистые заболе- вания. Бюллетень НЦССХ им. А.Н. Бакулева РАМН. Тезисы докла- дов 16-го Всероссийского съезда сердечно-сосудистых хирургов, Москва, 28 ноября-1 декабря. 2010; 11(6): 262.
- Kalinin R.E., Schvalb P.G., Chervyakov Yu.V. et al. Vascular endothelial growth factor-induced angiogenic gene therapy in patients with peripheral artery disease, phase I-IIa and IIb-III study. The European Society for Cardiovascular and Endovascular Surgery 60th International Congress. Moskow, May 20-22, 2011. Inter. Cardiovasc. Thoracic Surg. 2011; Suppl 1., 12: S74.
Supplementary files
