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Link to Youtube Video - Application of Heberprot-P in Venezuela (Spanish)
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{{Underlinked|date=June 2013}}
{{Underlinked|date=June 2013}}


'''Heberprot-P''' is the brand name of a drug developed by scientists at the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba as a cure for [[diabetic foot ulcer]].<ref name="APDS 2013">{{cite journal|url=http://omicsgroup.org/journals/medication-safety-in-hospitals-avoiding-medication-errors-in-the-medication%20use-process-2167-1052.1000134.pdf |title=Medical Practice Confirms Clinical Trial Results of the Use of Intralesional Human Recombinant Epidermal Growth Factor in Advanced Diabetic Foot Ulcers |journal=Advances in Pharmacoepidemiology & Drug Safety |year=2013 |volume=2 |issue=2 |first=Pedro A. |last=López-Saura ||first2=Isis B. |last2=Yera-Alos |first3=Carmen |last3=Valenzuela-Silva |first4=Odalys |last4=González-Díaz |first5=Amaurys |last5=del Río-Martín |first6=Jorge |last6=Berlanga-Acosta |first7=José I. |last7=Fernández-Montequín |first8=Boris |last8=Acevedo-Castro |first9=Ernesto |last9=López-Mola |first10=Luis |last10=Herrera-Martínez}}</ref> The product contains [[epidermal growth factor]] (EGF) to be applied by intra-lesional injections directly in the wound site.<ref>{{cite web|url=http://heberprot-p.cigb.edu.cu/index.php?option=com_content&view=article&id=17&Itemid=32&lang=en |title=Prescription Information |publisher=Center for Genetic Engineering and Biotechnology, Ave. 31 e/ 158 y 190, Cubanacán, Playa La Habana, Cuba |year=2010|accessdate=2012-09-08}}</ref><ref>{{cite journal |title=Heberprot-P: a novel product for treating advanced diabetic foot ulcer |last=Berlanga |first=J. |last2=Fernández |first2=J. I. |last3=López |first3=E. |last4=López |first4=P. A. |last5=del Río |first5=A. |last6=Valenzuela |first6=C. |last7=Baldomero |first7=J. |last8=Muzio |first8=V. |last9=Raíces |first9=M. |last10=Silva |first10=R. |last11=Acevedo |first11=B. E. |last12=Herrera |first12=L. |journal=[[MEDICC|MEDICC Review]] |year=2013 |volume=15 |issue=1 |pages=11–15 |pmid=23396236}}</ref> It has been found to "promote granulation and healing in advanced diabetic foot ulcers".<ref>{{cite web|url=http://onlinelibrary.wiley.com/doi/10.1111/j.1742-481X.2009.00641.x/full |title=Intra-lesional injections of recombinant human epidermal growth factor promote granulation and healing in advanced diabetic foot ulcers: multicenter, randomised, placebo-controlled, double-blind study |publisher=International Wound Journal |date=December 2009|pages= 432–443| doi= 10.1111/j.1742-481X.2009.00641.x |accessdate=2012-09-08}}</ref>
'''Heberprot-P''' is the brand name of a drug developed by scientists at the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba as a cure for [[diabetic foot ulcer]].<ref name="APDS 2013">{{cite journal|url=http://omicsgroup.org/journals/medication-safety-in-hospitals-avoiding-medication-errors-in-the-medication%20use-process-2167-1052.1000134.pdf |title=Medical Practice Confirms Clinical Trial Results of the Use of Intralesional Human Recombinant Epidermal Growth Factor in Advanced Diabetic Foot Ulcers |journal=Advances in Pharmacoepidemiology & Drug Safety |year=2013 |volume=2 |issue=2 |first=Pedro A. |last=López-Saura ||first2=Isis B. |last2=Yera-Alos |first3=Carmen |last3=Valenzuela-Silva |first4=Odalys |last4=González-Díaz |first5=Amaurys |last5=del Río-Martín |first6=Jorge |last6=Berlanga-Acosta |first7=José I. |last7=Fernández-Montequín |first8=Boris |last8=Acevedo-Castro |first9=Ernesto |last9=López-Mola |first10=Luis |last10=Herrera-Martínez}}</ref> The product contains [[epidermal growth factor]] (EGF) to be applied by intra-lesional injections directly in the wound site.<ref>{{cite web|url=http://heberprot-p.cigb.edu.cu/index.php?option=com_content&view=article&id=17&Itemid=32&lang=en |title=Prescription Information |publisher=Center for Genetic Engineering and Biotechnology, Ave. 31 e/ 158 y 190, Cubanacán, Playa La Habana, Cuba |year=2010|accessdate=2012-09-08}}</ref><ref>{{cite journal |title=Heberprot-P: a novel product for treating advanced diabetic foot ulcer |last=Berlanga |first=J. |last2=Fernández |first2=J. I. |last3=López |first3=E. |last4=López |first4=P. A. |last5=del Río |first5=A. |last6=Valenzuela |first6=C. |last7=Baldomero |first7=J. |last8=Muzio |first8=V. |last9=Raíces |first9=M. |last10=Silva |first10=R. |last11=Acevedo |first11=B. E. |last12=Herrera |first12=L. |journal=[[MEDICC|MEDICC Review]] |year=2013 |volume=15 |issue=1 |pages=11–15 |pmid=23396236}}</ref> <ref>http://www.youtube.com/watch?v=gHTs442zuJA</ref>It has been found to "promote granulation and healing in advanced diabetic foot ulcers".<ref>{{cite web|url=http://onlinelibrary.wiley.com/doi/10.1111/j.1742-481X.2009.00641.x/full |title=Intra-lesional injections of recombinant human epidermal growth factor promote granulation and healing in advanced diabetic foot ulcers: multicenter, randomised, placebo-controlled, double-blind study |publisher=International Wound Journal |date=December 2009|pages= 432–443| doi= 10.1111/j.1742-481X.2009.00641.x |accessdate=2012-09-08}}</ref>
Heberprot-P is indicated for the treatment of poor prognosis of deep, extensive, and terminal DFU not responding to comprehensive and/or extensive conventional methods, particularly in grades 3, 4 and 5 of Wagner's Classification with average ulcer size bigger than 20 cm<sup>2</sup>,<ref name="APDS 2013"/> of both neuropathic and ischemic etiology with high risk amputation. Clinical studies in 344 patients with advanced diabetic foot ulcers (Wagner´s grade 3 or 4, median size >20 cm<sup>2</sup>, ischemic ulcers not excluded) have shown that injected recombinant EGF has the potential to promote complete granulation in more than 80%, with complete wound healing (re-epithelialization) in more than 50% of subjects usually unresponsive to other treatments. Injected recombinant EGF has the potential to reduce amputation rates, with a considerable personal and public health improvement, including longer survival.<ref name="APDS 2013"/>
Heberprot-P is indicated for the treatment of poor prognosis of deep, extensive, and terminal DFU not responding to comprehensive and/or extensive conventional methods, particularly in grades 3, 4 and 5 of Wagner's Classification with average ulcer size bigger than 20 cm<sup>2</sup>,<ref name="APDS 2013"/> of both neuropathic and ischemic etiology with high risk amputation. Clinical studies in 344 patients with advanced diabetic foot ulcers (Wagner´s grade 3 or 4, median size >20 cm<sup>2</sup>, ischemic ulcers not excluded) have shown that injected recombinant EGF has the potential to promote complete granulation in more than 80%, with complete wound healing (re-epithelialization) in more than 50% of subjects usually unresponsive to other treatments. Injected recombinant EGF has the potential to reduce amputation rates, with a considerable personal and public health improvement, including longer survival.<ref name="APDS 2013"/>


Revision as of 20:28, 19 October 2014

Heberprot-P is the brand name of a drug developed by scientists at the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba as a cure for diabetic foot ulcer.[1] The product contains epidermal growth factor (EGF) to be applied by intra-lesional injections directly in the wound site.[2][3] [4]It has been found to "promote granulation and healing in advanced diabetic foot ulcers".[5] Heberprot-P is indicated for the treatment of poor prognosis of deep, extensive, and terminal DFU not responding to comprehensive and/or extensive conventional methods, particularly in grades 3, 4 and 5 of Wagner's Classification with average ulcer size bigger than 20 cm2,[1] of both neuropathic and ischemic etiology with high risk amputation. Clinical studies in 344 patients with advanced diabetic foot ulcers (Wagner´s grade 3 or 4, median size >20 cm2, ischemic ulcers not excluded) have shown that injected recombinant EGF has the potential to promote complete granulation in more than 80%, with complete wound healing (re-epithelialization) in more than 50% of subjects usually unresponsive to other treatments. Injected recombinant EGF has the potential to reduce amputation rates, with a considerable personal and public health improvement, including longer survival.[1]

Clinical trials and use

The drug is currently in use in Cuba (since 2007[6]), Argentina, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Panama,[7][verification needed] Paraguay, Peru, Uruguay, Venezuela[8] , Russia, Turkey[9] and in the Domenican Republicand, Vietnam, and the Philippines. Heberprot-P is protected by World patent WO PCT/CU2002/000011.[10]As of July 2012, China has started advanced stage-three tests of the drug, along with colleagues at 100 hospitals throughout the European Union. These trials are the first time Cuban scientists have undertaken advanced clinical trials in developed countries.[11]

The drug has seen successful use in Algeria where at least 700 patients with diabetes could avoid amputation and another 3000 cases of gangrene have been treated. A local firm is manufacturing the drug in Algeria.[12]

In South-east Asian countries such as Vietnam and the Philippines, the drug is being used as an advanced wound care healing drug and may be accessed through wound care clinics or wound care specialists among hospitals.[citation needed]

References

  1. ^ a b c López-Saura, Pedro A.; Yera-Alos, Isis B.; Valenzuela-Silva, Carmen; González-Díaz, Odalys; del Río-Martín, Amaurys; Berlanga-Acosta, Jorge; Fernández-Montequín, José I.; Acevedo-Castro, Boris; López-Mola, Ernesto; Herrera-Martínez, Luis (2013). "Medical Practice Confirms Clinical Trial Results of the Use of Intralesional Human Recombinant Epidermal Growth Factor in Advanced Diabetic Foot Ulcers" (PDF). Advances in Pharmacoepidemiology & Drug Safety. 2 (2). {{cite journal}}: Cite has empty unknown parameter: |1= (help)
  2. ^ "Prescription Information". Center for Genetic Engineering and Biotechnology, Ave. 31 e/ 158 y 190, Cubanacán, Playa La Habana, Cuba. 2010. Retrieved 2012-09-08.
  3. ^ Berlanga, J.; Fernández, J. I.; López, E.; López, P. A.; del Río, A.; Valenzuela, C.; Baldomero, J.; Muzio, V.; Raíces, M.; Silva, R.; Acevedo, B. E.; Herrera, L. (2013). "Heberprot-P: a novel product for treating advanced diabetic foot ulcer". MEDICC Review. 15 (1): 11–15. PMID 23396236.
  4. ^ http://www.youtube.com/watch?v=gHTs442zuJA
  5. ^ "Intra-lesional injections of recombinant human epidermal growth factor promote granulation and healing in advanced diabetic foot ulcers: multicenter, randomised, placebo-controlled, double-blind study". International Wound Journal. December 2009. pp. 432–443. doi:10.1111/j.1742-481X.2009.00641.x. Retrieved 2012-09-08.
  6. ^ http://www.ncbi.nlm.nih.gov/pubmed/23396236
  7. ^ "Technical File in the Public Health Database" (in Spanish). Comité Técnico Nacional Interinstitucional. Retrieved October 19, 2014.
  8. ^ http://www.youtube.com/watch?v=f6iE8rEcrKU
  9. ^ "Heberprot-P registered in Turkey". Granma International. September 29, 2014. Retrieved October 19, 2014.
  10. ^ http://www.google.com/patents/CA2470971C?cl=en
  11. ^ "China, Russia to test Cuban diabetes drug". Xinhua English. 2012-07-20. Retrieved 2012-09-09.
  12. ^ Khris, Badreddine (November 18, 2013). "Traitement du pied diabétique. Heberprot-P, une efficacité avérée !". Liberté (in French). Retrieved October 19, 2014. {{cite news}}: Unknown parameter |trans_title= ignored (|trans-title= suggested) (help)
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