“Neutral Allografts”-Lack of Allogeneic Stimulation by Cultured Human Cells Expressing MHC Class I and Class Ii Antigens

Theobald, Valerie; Lauer, Jeffrey; Kaplan, Faith A.; Baker, Katherine B.; Rosenberg, Mireille

doi:10.1097/00007890-199301000-00024

Cited by 56 publications

(28 citation statements)

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“…Graftskin has been shown in previous studies not to elicit an immunological response from the host, and this finding was confirmed in this study (10,23). Graftskin was also not associated with any other adverse effects, such as wound infection and cellulitis, when compared with the control group.…”

Section: Immune Responsesupporting

confidence: 89%

Graftskin, a Human Skin Equivalent, Is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers

Veves

Falanga

Armstrong³

et al. 2001

Diabetes Care

652

433

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OBJECTIVE— We assessed in a randomized prospective trial the effectiveness of Graftskin, a living skin equivalent, in treating noninfected nonischemic chronic plantar diabetic foot ulcers. RESEARCH DESIGN AND METHODS— In 24 centers in the U.S., 208 patients were randomly assigned to ulcer treatment either with Graftskin (112 patients) or saline-moistened gauze (96 patients, control group). Standard state-of-the-art adjunctive therapy, which included extensive surgical debridement and adequate foot off-loading, was provided in both groups. Graftskin was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks (maximum of five applications) or earlier if complete healing occurred. The major outcome of complete wound healing was assessed by intention to treat at the 12-week follow-up visit. RESULTS— At the 12-week follow-up visit, 63 (56%)Graftskin-treated patients achieved complete wound healing compared with 36(38%) in the control group (P = 0.0042). The Kaplan-Meier median time to complete closure was 65 days for Graftskin, significantly lower than the 90 days observed in the control group (P = 0.0026). The odds ratio for complete healing for a Graftskin-treated ulcer compared with a control-treated ulcer was 2.14 (95% CI 1.23-3.74). The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis and lower-limb amputations, both of which were less frequent in the Graftskin group. CONCLUSIONS— Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently available treatment and is not associated with any significant side effects. Graftskin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available standard of care.

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Section: Immune Responsesupporting

confidence: 89%

Graftskin, a Human Skin Equivalent, Is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers

Veves

Falanga

Armstrong³

et al. 2001

Diabetes Care

652

433

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“…Wound-healing products based on cytokines or growth factors, e.g., platelet-derived growth factor-(3, basic fibroblast growth factor, transforming growth factor-P, and granulocyte-macrophage colonystimulating factor, are presently available or under investigation (2,3,7,16 (6,9,20). These results are in agreement with published data indicating that cultured keratinocytes and fibroblasts are of low antigenicity and immunogenicity (11,19 (8,12).…”

Section: Introductionsupporting

confidence: 85%

Safety Evaluation of Human Living Skin Equivalents

Nemecek

Dayan

1999

Toxicol Pathol

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“…Fibroblasts rapidly proliferate in culture, are extremely hardy and thus are very frequently used for ex vivo gene therapy and cell transplantation work. [22][23][24][25] Fibroblasts are already approved for human implantation. A tissue-engineered, Food and Drug Administration-approved, artificial skin containing fibroblast allografts harvested from neonatal skin samples has been available for treatment of nonhealing ulcers and other cutaneous defects.…”

Section: Discussionmentioning

confidence: 99%

Endovascular Treatment of Experimental Aneurysms by Use of Fibroblast-Coated Platinum Coils

Dai

Ding

Danielson

et al. 2007

Stroke

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Background and Purpose-The purpose of this study was to determine whether implanting exogenous fibroblasts on platinum coils could enhance intra-aneurysmal fibrosis. Hypotheses included: (1) fibroblast-coated (FBC) platinum coils can improve angiographic results after embolization; and (2) FBC platinum coils can accelerate histological healing of embolized aneurysms. Methods-Experimental aneurysms in rabbits were embolized with control platinum coils (nϭ18) or FBC coils (nϭ18).Subjects were euthanized at 14 days, 1 month, 3 months and 6 months after implantation. Digital subtraction angiography was used to evaluate stability after embolization. Histological samples were examined with a grading system (range, 0 to 12) based on neck and dome healing. Results-Histology total scores and fibrosis ratio at 14 days were significantly greater in the FBC coil group compared with controls (6.6Ϯ1.9 versus 2.5Ϯ1.1, 1.2Ϯ0.6% versus 0.2Ϯ0.3%, respectively; Pϭ0.0090). Cavities embolized with FBC coils showed cellular proliferation and thrombus organization, with an endothelialized membrane bridging the neck. There were no differences between groups in the later timepoints. The FBC coil group showed radiographic stability in 11 (61%) cases, coil compaction in 2 (11%) cases, and progressive occlusion in 5 (28%) cases. No progressive occlusion was seen in controls; 3 (17%) of 18 control cases exhibited coil compaction (Pϭ0.0546). Conclusions-FBC

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“Neutral Allografts”-Lack of Allogeneic Stimulation by Cultured Human Cells Expressing MHC Class I and Class Ii Antigens

Cited by 56 publications

References 0 publications

Graftskin, a Human Skin Equivalent, Is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers

Graftskin, a Human Skin Equivalent, Is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers

Safety Evaluation of Human Living Skin Equivalents

Endovascular Treatment of Experimental Aneurysms by Use of Fibroblast-Coated Platinum Coils

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