Artificial skin (Bio-inspired bi-layer polymeric hybrid scaffold) for burn injuries and trauma care
Primary Information
Domain
Healthcare
Project No.
5653
Sanction and Project Initiation
Sanction No: F.NO.41-2/2015-T.S.I( PT)( ANN.I SL.24)
Sanction Date: 09/01/2016
Project Initiation date: 27/03/2017
Project Duration: 36
Partner Ministry/Agency/Industry
Ministry of Health and Family Welfare Ministry of Human Resource Development Saveer BioTech Ltd
Role of partner: Partner should take the technology once the product is evaluated for burn wounds in animal model.
Support from partner: Company has initiated the setting of Lab for Processing/ Manufacturing of Medical Devices.The company is also in process of market evaluation and analysis of the marketing potential of the project.
Principal Investigator
Veena KoulPrimary
Centre for Biomedical Engineering, Indian Institute of Technology Delhi
Host Institute
Co-PIs
Amit k Dinda
Department of Pathology All India Institute of Medical Sciences
Maneesh Singhal
Head, Department of Plastic Reconstructive and Burns Surgery, All India Institute of Medical Sciences, India
Scope and Objectives
Objectives: Objective of this project was to examine the efficacy of the hybrid hydrogel scaffold on burn wound animal model , which will further be translated to human patients due to biocompatible nature of its constituents (Phase I clinical Trials ). The idea is to provide a substitute alternative for patients own skin grafting or cadaver skin application. The proposed scaffold will become part of the skin will act as a skin substitute. We hypothesize that it will take 3-4 weeks to completely heal patients with surgically created donor areas by harvesting graft and flaps.
Deliverables
Bio inspired Scaffold for 2nd Degree burn wounds and Trauma care. Scaffold can be fabricated in different size and dimension as needed. Depending on depth of the burn wound hydrogel based scaffold will be manipulated and applied. Suturing can be performed to retain the scaffold over the wound bed. Semi wetted scaffold will be applied on the wound bed and will be covered with a polymeric membrane which will provide aeration to the wound. We hypothesized that the proposed scaffold will provide an alternative to autologous skin grafting as well as substitute to cadaveric skin grafting too. Thus it will act as skin substitute
Scientific Output
Formulation and optimization of biodegradable patch based scaffold -- Completed. Cyto -compatibility studies ( In vitro) --completed Bio compatibility studies on rat model Completed
Results and outcome till date
The analysis of blood parameters & histopathology of tissue and organs of Wistar rats has revealed that their is no toxicity associated with the scaffold and proven its efficacy to marketed scaffold . The ELISA studies of serum of Wistar rats related to collagen markers has shown their up- regulation . C3a, TNF alpha and IL-1 alpha studies on serum samples were comparable to marketed scaffold
Societal benefit and impact anticipated
The proposed scaffold will provide an alternative to autologous skin grafting as well as substitute to cadaveric skin grafting too. Thus it will act as skin substitute
Next steps
1 Gamma Sterilization stability on the scaffold . Comparative studies on Pre and Post sterilization by Gamma on the scaffold has been initiated
2. Ethical Approvals have been obtained to conduct experiment on 2nd degree Burn wound model of rat.
3. Animal Experimentation studies ( Burn Wound ) will be initiated after the scaffold is validated for sterilization stability.
Publications and reports
Already papers are published & patented with the electropsun based scaffolds. Biomaterials 88 (2016): 83-96, J Mater Sci Mater Med. 2017 Aug;28(8):128 Mater SciEng C Mater Biol Appl. 2017 Oct 1;79:15-22. Journal of Biomedical Nanotechnology 2013 ,Vol. 9, 1495-508 .Paper has been communicated
Patents
1. A Triple Layer Dressing for Wound Healing, VeenaKoul, ManeeshJaiswal. Patent Application No.315/DEL/2012
2. Additional up gradation of the above patent was filed in the month of April-2016.VeenaKoul, SirsenduBhowmick, Thanusha AV Indian Patent Application No. 201613015936
Scholars and Project Staff
Mrs. Navita Sharma 6 months till June 2019Scientist Dr. Aradhana 6 Months till June 2019 Research Scholar Thanusha AV
Challenges faced
Gelatin procurement from Sigma during first year was impossible as they had stopped its supply to India. Equipment procurement and animal Ethical approvals took lot of time
Other information
The Biocompatibility studies under ISO 10993 is being evaluated by a GLP lab . The results will be completed by August end
Financial Information
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Total sanction: Rs. 22214400
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Amount received: Rs. 11565053
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Amount utilised for Equipment: Rs. 2752840
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Amount utilised for Manpower: Rs. 1585026
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Amount utilised for Consumables: Rs. 2059243
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Amount utilised for Contingency: Rs. 108031
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Amount utilised for Travel: Rs. 17981
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Amount utilised for Other Expenses: 130000
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Amount utilised for Overheads: Rs. 1590833
Equipment and facilities
Lyophilizer Electronic Balance Stirrers UPS
