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Phase I study of direct administration of a replication deficient adenovirus vector containing the vascular endothelial growth factor cDNA (CI-1023) to patients with claudication.
Am J Cardiol. 2002 Sep 01; 90(5):512-6.AJ

Abstract

The long-term safety and efficacy of adenoviral delivery of growth factors in patients with peripheral arterial disease (PAD) is unknown. CI-1023 (Ad(GV)VEGF(121.10)) is a replication-deficient adenovirus encoding human vascular endothelial growth factor isoform 121. In this phase I trial, we investigated the safety and efficacy of CI-1023 in subjects with advanced claudication symptoms secondary to infra-inguinal disease. Eighteen subjects >35 years of age with a median ankle brachial index (ABI) at rest of 0.525 (interquartile range 0.4) and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 x10(8) to 4 x10(10) particle units, n = 15) or placebo (n = 3). Eleven of 15 patients (73%) who received CI-1023 and 1 of 3 subjects (33%) who received placebo, completed 1 year of follow-up. Edema and rash were the most common early adverse event. One infra-inguinal bypass procedure occurred in each of the placebo and CI-1023 groups at days 29 and 104, respectively. One death (day 160) and 1 malignancy (day 274) occurred in the CI-1023 group. Conclusions on efficacy could not be made due to the small number of patients. However, there were encouraging trends in ABI at rest and peak walking time at follow-up.

Authors+Show Affiliations

Division of Cardiology, University of Michigan, Ann Arbor, Michigan 48109, USA. srajagop@umich.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase I
Journal Article
Multicenter Study

Language

eng

PubMed ID

12208412

Citation

Rajagopalan, Sanjay, et al. "Phase I Study of Direct Administration of a Replication Deficient Adenovirus Vector Containing the Vascular Endothelial Growth Factor cDNA (CI-1023) to Patients With Claudication." The American Journal of Cardiology, vol. 90, no. 5, 2002, pp. 512-6.
Rajagopalan S, Trachtenberg J, Mohler E, et al. Phase I study of direct administration of a replication deficient adenovirus vector containing the vascular endothelial growth factor cDNA (CI-1023) to patients with claudication. Am J Cardiol. 2002;90(5):512-6.
Rajagopalan, S., Trachtenberg, J., Mohler, E., Olin, J., McBride, S., Pak, R., Rasmussen, H., & Crystal, R. (2002). Phase I study of direct administration of a replication deficient adenovirus vector containing the vascular endothelial growth factor cDNA (CI-1023) to patients with claudication. The American Journal of Cardiology, 90(5), 512-6.
Rajagopalan S, et al. Phase I Study of Direct Administration of a Replication Deficient Adenovirus Vector Containing the Vascular Endothelial Growth Factor cDNA (CI-1023) to Patients With Claudication. Am J Cardiol. 2002 Sep 1;90(5):512-6. PubMed PMID: 12208412.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase I study of direct administration of a replication deficient adenovirus vector containing the vascular endothelial growth factor cDNA (CI-1023) to patients with claudication. AU - Rajagopalan,Sanjay, AU - Trachtenberg,Jeffrey, AU - Mohler,Emile, AU - Olin,Jeffrey, AU - McBride,Scott, AU - Pak,Raphael, AU - Rasmussen,Henrik, AU - Crystal,Ronald, PY - 2002/9/5/pubmed PY - 2002/10/3/medline PY - 2002/9/5/entrez SP - 512 EP - 6 JF - The American journal of cardiology JO - Am J Cardiol VL - 90 IS - 5 N2 - The long-term safety and efficacy of adenoviral delivery of growth factors in patients with peripheral arterial disease (PAD) is unknown. CI-1023 (Ad(GV)VEGF(121.10)) is a replication-deficient adenovirus encoding human vascular endothelial growth factor isoform 121. In this phase I trial, we investigated the safety and efficacy of CI-1023 in subjects with advanced claudication symptoms secondary to infra-inguinal disease. Eighteen subjects >35 years of age with a median ankle brachial index (ABI) at rest of 0.525 (interquartile range 0.4) and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 x10(8) to 4 x10(10) particle units, n = 15) or placebo (n = 3). Eleven of 15 patients (73%) who received CI-1023 and 1 of 3 subjects (33%) who received placebo, completed 1 year of follow-up. Edema and rash were the most common early adverse event. One infra-inguinal bypass procedure occurred in each of the placebo and CI-1023 groups at days 29 and 104, respectively. One death (day 160) and 1 malignancy (day 274) occurred in the CI-1023 group. Conclusions on efficacy could not be made due to the small number of patients. However, there were encouraging trends in ABI at rest and peak walking time at follow-up. SN - 0002-9149 UR - https://www.unboundmedicine.com/medline/citation/12208412/Phase_I_study_of_direct_administration_of_a_replication_deficient_adenovirus_vector_containing_the_vascular_endothelial_growth_factor_cDNA__CI_1023__to_patients_with_claudication_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002914902025249 DB - PRIME DP - Unbound Medicine ER -