 India's First Recombinant Human Epidermal Growth Factor, indigenously developed by Bharat Biotech
REGEN-D™ 150
(recombinant human Epidermal Growth Factor)
Epidermal Growth Factor (EGF) is a small 53 amino acid residue long protein that contains three disulfide bridges. It is a small mitogenic protein that is involved in normal cell growth and wound healing. REGEN-D™ 150 is manufactured using recombinant DNA technology.
EGF - Signal Transduction Pathway
Epidermal Growth Factor (EGF) peptide induces cellular proliferation through the EGF receptor, which has a tyrosine kinase cytoplasmic domain, a single transmembrane domain and an extracellular domain involved in EGF binding and receptor dimerization. The proliferative effects of EGF are signaled through several pathways. Binding of EGF results in EGF receptor dimerization, autophosphorylation of the receptor, and tyrosine phosphorylation of other proteins. EGF receptor activates MAP kinase pathway, ultimately causing phosphorylation of transcription factors that contribute to proliferation.
CLINICAL TRIALS
Preclinical Studies
The preclinical animal toxicological evaluation of REGEN-D™ 150 was done at Pharmacology Evaluation Centre, Indian Institute of Chemical Technology (IICT), Hyderabad. Preclinical toxicity studies at all stages concluded and proven to be highly safe.
Multi-centric, Phase III Trials
A Multi-centre, Double blind, randomized (1:1), parallel, Phase III study to evaluate the safety and efficacy of Regen-D in comparison with a placebo (2 groups; Group I: REGEN-DTM 150 and Group II: Placebo) as a treatment for
- DIABETIC FOOT ULCERS
- FIRST & SECOND DEGREE BURNS
- DONOR SITE SKIN GRAFTS
Phase III trials were conducted at 5 centers across the country with the objective to evaluate the safety and efficacy of REGEN-D™ manufactured in two concentrations of REGEN-D™ 150 (150 µg /gm) and REGEN-D™ 60 (60µg /gm). REGEN-D™ 150 was tested in Diabetic Foot Ulcers (Grade I or II, Wagner's Classification) and REGEN-D™ 60 was tested in Donor Site Skin grafts, First & Second degree burns.
Presentation
REGEN-D™ 150 is available in gel base in tubes as:
REGEN-DTM 150 (150 µg / gm); available in 7.5 gms and 15 gms tube
Dosage
REGEN-D™ 150: Apply topically twice daily for diabetic foot ulcers.
Clinical Guidelines for the Application of REGEN-D™ 150
Basic wound management has to be followed before application of REGEN-D™ 150.
A thin film of REGEN-D™ 150 gel must be applied topically on the wound area with a sterile cotton swab. Clinical management guidelines must be followed before application of REGEN-D™ 150
REGEN-D™ 150 for Diabetic Foot Ulcers
- Surgical debridement of the wound to drain the pus and necrotic tissues at the ulcer area
- Clean the wound with saline solution to wash away the loose necrotic tissue.
- After basic wound management is done apply REGEN-D™ 150
- Apply a thin continuous film of REGEN-D™ 150 gel with a sterile cotton swab or with an applicator, over the entire wound area
- Proper care should be taken so that a thin film of gel covers the entire ulcer area
- The ulcer area should be covered with a moist dressing and then by a dry cotton pad
- After 10 -12 hrs of application, remove the bandage and wash the ulcer area with saline
- REGEN-D™ 150 gel application should be continued till the ulcer area heals completely
Antibiotic Therapy in Diabetic Foot Ulcer treatment during REGEN-D™ 150
Infection in diabetic foot has usually deep seated locus. On culture it has been noted these are polymicrobial. It is always preferable to use systemic antibiotics with / without. topical antibiotics. The choice and duration of antibiotics depends on the severity of infection and microbial culture reports. Antibiotic should be instituted just after collecting swab for culture and sensitivity. Start with a combination of three antibiotics these include:
- against gram positive organisms
- against gram negative organisms
- for anaerobic organisms. The ideal condition for a growth factor is a sterile/ clean uninfected ulcer. Judicious use of antibiotics is advised before REGEN-D™ 150 is applied, there by further reducing wound healing time
General Guidelines
The patient must be euglycemic on proper medication
Standard foot care and ulcer management guidelines should be adhered while using REGEN-D™ 150 gel.
Note: REGEN-D™ 150 gel is a wound healing agent and it has no role in curing / treating the disease condition
Storage
Store at 2-8oC. Do not Freeze.
Shelf Life
2 years from the date of manufacture.
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