This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Beele, H. Articles by Verbeken, G. Search for Related Content PubMed PubMed Citation Articles by Beele, H. Articles by Verbeken, G. Social Bookmarking                         What's this?

A Prospective Multicenter Study of the Efficacy and Tolerability of Cryopreserved Allogenic Human Keratinocytes to Treat Venous Leg Ulcers

University Hospital, Department of Dermatology, Ghent, Belgium

M. de la Brassine

University Hospital, Department of Dermatology, Liége Belgium

J. Lambert

University Hospital, Department of Dermatology, Edegem, Belgium

E. Suys

Private practice, Kortrijk, Belgium

C. De Cuyper

General Hospital St-Jan, Department of Dermatology, Brugge, Belgium

J. Decroix

Private practice, Mouscron, Belgium

B. Boyden

Private practice, Hasselt, Belgium

L. Tobback

Innogenetics, Gent, Belgium

F. Hulstaert

Innogenetics, Gent, Belgium

S. De Schepper

Innogenetics, Gent, Belgium

J. Brissinck

Innogenetics, Gent, Belgium

B. Delaey

XCEL Lentis, Merelbeke, Belgium

J.-P. Draye

XCEL Lentis, Merelbeke, Belgium

A. De Deene

XCEL Lentis, Merelbeke, Belgium

P. De Waele

XCEL Lentis, Merelbeke, Belgium

G. Verbeken

XCEL Lentis, Merelbeke, Belgium

Allogeneic human keratinocyte cultures have been used to treat burn wounds, donor sites, and chronic skin ulcers with some success. Cryopreservation of these cultures allows for the production of large standardized batches that are readily available for use. The aim of the study presented in this report was to study effects of cryopreserved cultured allogenic human keratinocytes (Cryo Ceal) on chronic lower extremity wounds. Parameters were measured to study efficacy, tolerability, pain associated with chronic wounds, and quality of life of patients. Twenty-seven patients with hard-to-heal venous leg ulcers received a maximum of 9 applications of Cryo Ceal in a prospective, uncontrolled multicenter study lasting 48 weeks. Eleven out of 27 patients (41%; 95% CI: 22%-61%) had complete wound closure within 24 weeks (1 week). The time required for complete wound closure in these 11 patients ranged from 4.1 to 24.9weeks. Only 1 patient had recurrence of the ulcer at 48 weeks. Local (wound) pain scores decreased from a mean of 2.5 at baseline to 0.9 at week 24. Fifty percent of the patients attained a pain score of 0 after 12 weeks and remained stable at this score until the end of the study. Overall, the patient quality of life was better at week 24, compared to baseline values. The treatment was well tolerated, and wound infection was the most frequently occurring adverse event.

Key Words: cryopreserved human keratinocytes • venous leg ulcers • quality of life • tissue engineerin

The International Journal of Lower Extremity Wounds, Vol. 4, No. 4, 225-233 (2005)
DOI: 10.1177/1534734605282999


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?