REGRANEX SUMMARY
REGRANEX® Gel contains becaplermin, a recombinant human platelet-derived growth factor (rhPDGF-BB) for topical administration. Becaplermin is produced by recombinant DNA technology by insertion of the gene for the B chain of platelet-derived growth factor (PDGF) into the yeast, Saccharomyces cerevisiae.
REGRANEX (becaplermin) Gel is indicated for the treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. When used as an adjunct to, and not a substitute for, good ulcer care practices including initial sharp debridement, pressure relief and infection control, REGRANEX Gel increases the incidence of complete healing of diabetic ulcers.
The efficacy of REGRANEX Gel has not been established for the treatment of pressure ulcers and venous stasis ulcers (See Clinical Studies) and has not been evaluated for the treatment of diabetic neuropathic ulcers that do not extend through the dermis into subcutaneous tissue (Stage I or II, IAET staging classification) or ischemic diabetic ulcers.
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NEWS HIGHLIGHTS
Published Studies Related to Regranex (Becaplermin)
A matched cohort study of the risk of cancer in users of becaplermin. [2011.01]
BACKGROUND: Becaplermin is recombinant human platelet-derived growth factor for topical administration that might plausibly be related to cancer risk. Extended follow-up of patients from clinical trials of becaplermin compared with placebo identified a relative risk of cancer of 2.8 (95% confidence interval [CI], 0.6-12.8). The authors aimed to further investigate any association between becaplermin use and the occurrence of cancer by following a large cohort of patients in a clinical practice setting... CONCLUSIONS: Becaplermin does not appear to increase the risk of cancer or cancer mortality.
Benefit-risk assessment of becaplermin in the treatment of diabetic foot ulcers. [2010.06.01]
Becaplermin is a recombinant platelet-derived growth factor composed of two B chains that is approved for the treatment of neuropathic diabetic foot ulcers extending into or beyond the subcutaneous tissue in patients with adequate arterial perfusion... Finally, longer follow-up data are necessary to shed more light on the potential risk of malignancy in connection with becaplermin use.
Diabetic foot ulcers treated with becaplermin and TheraGauze, a moisture-controlling smart dressing: a randomized, multicenter, prospective analysis. [2010.05]
BACKGROUND: It is hypothesized that moisture regulation specific to the area of contact results in local wound conditions more amenable to healing, which would result in faster and more frequent wound closure. TheraGauze is a new polymer-impregnated dressing designed to regulate moisture to a varying degree over the entire surface of a wound... CONCLUSIONS: Wounds in which moisture content was regulated with TheraGauze showed more rapid change in wound area and a higher percentage of wounds achieving closure at 12 and 20 weeks regardless of whether becaplermin was used.
Diabetic foot ulcers treated with becaplermin and TheraGauze, a
moisture-controlling smart dressing: a randomized, multicenter, prospective
analysis. [2010]
over the entire surface of a wound... CONCLUSIONS: Wounds in which moisture content was regulated with TheraGauze
Treatment factors influencing the use of recombinant platelet-derived growth factor (Regranex) for head and lateral line erosion syndrome in ocean surgeonfish (Acanthurus bahianus). [2008.06]
The clinical efficacy of becaplermin (Regranex, Ortho-McNeil Pharmaceutical, Inc., Raritan, New Jersey 08869) on head and lateral line erosion syndrome (HLLES) in ocean surgeonfish (Acanthurus bahianus) was examined in a two-part study to determine suitable application frequencies of the drug and the effects of the environment on outcome of treatments...
Clinical Trials Related to Regranex (Becaplermin)
Comparing the Efficacy and Safety of Three Dose Regimens of BioChaperone PDGF-BB to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer [Recruiting]
This is an open-label, active-control, multicentre, parallel group, randomised and
dose-finding efficacy and safety study.
Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12. 5 µg/cm² every two
days for up to 20 weeks to becaplermin gel (Regranex® Gel 0. 01%) applied daily for up to 20
weeks for the treatment of neuropathic diabetic foot ulcer.
Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two
days for up to 20 weeks.
Evaluation of Windowed Casts With and Without Regranex� Gel for Healing Diabetic Neuropathic Ulcers [Recruiting]
The objective of this study is to compare the effectiveness and safety of windowed casts
with Regranex® (topical becaplermin gel) versus placebo (inactive medication) for treatment
of diabetic ulcers on the legs and feet.
Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis [Recruiting]
The purpose of this study is to determine whether recombinant human platelet-derived growth
factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis
elbow).
Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers [Not yet recruiting]
Diabetic foot ulcers, a complication of diabetes leading to 80. 000 lower limb amputations
annually in the US, are a significant burden to our health system, costing more than a
billion dollars annually. Here, we propose a novel combination of two drugs (Mozobil® and
Regranex®Gel) to mobilize a specific sub-type of stem cells (endothelial progenitor cells)
from the bone marrow and traffic them toward the wound, increasing the blood supply that
subsequently improves wound healing. Because we are using the human body's own resources to
regenerate itself by targeting and correcting the underlying pathophysiology, we believe
that this novel therapy yields great promise in the treatment of diabetic foot ulcers.
Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns [Not yet recruiting]
Platelet Derived Growth Factor (PDGF) is a potent mitogen for a wide range of cell types
including fibroblasts, smooth muscle and connective tissue. Recombinant human platelet
derived growth factor (R-Pdf/Gbb) has biologic activity similar to endogenous platelet
derived growth factor (PDGF). Biologic activity of PDGF includes encouraging chemotaxis and
proliferation of cells responsible for wound repair and it augments production of
granulation tissue.
The growth factor rhPDGF is found effective in patients having diabetic foot ulcer grade III
and IV. The nature of wounds in the third degree burns is similar so far as healing process
is concerned.
The purpose of this study is to test the hypotheses that the application of R-Pdf/Gbb 0. 01%
gel on the third degree thermal and electrical burns will heal these wounds within 3 months
and there will be improvement in general condition of the patients without any
complications.
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