“FESTIGEL” (Free-from-Endotoxin-excess-Scaffold of Thermoresponsive Intelli-GEL), is a tissue engineering polymer cocktail specially made for GN Corporation Co. Ltd., Japan, the parent company of MediNippon Healthcare Pvt. Ltd. It is based on the earlier reported Thermo-reversible Gelation Polymer (TGP) scaffold, which has been reported to have the following potentials:

  1. Ability to provide a three-dimensional cell culture platform
  2. Helps maintain cells and stem cells in their native phenotype for a longer period of time
  3. Helps maintain the potency of cells and stem cells, including documented growth of pluripotent stem cells from adult tissue
  4. Helps in the growth of cells with ECM secretion as a tissue
  5. Serves as a transportation cocktail that helps maintain the viability of cells and tissues transported in it without the need for cool preservation for up to 72 hours
  6. Serves as a transplantation scaffold for cells to be embedded and transplanted for in vivo regeneration

Festigel has also been cleared for safety and toxicity through the following tests, as per regulatory guidelines:

  1. Intraperitoneal, single-dose toxicity study in rats
  2. Intraperitoneal, single-dose toxicity study in rats
  3. Primary skin irritation study in rabbits
  4. Two-week cumulative skin irritation study in rabbits
  5. Two-week cumulative skin irritation study in rabbits
  6. Skin sensitization study in guinea pigs
  7. Reverse mutation study in bacteria
  8. In vitro chromosomal aberration test in mammalian cells
  9. Antigenicity study in guinea pigs — ASA reaction
  10. Antigenicity study in guinea pigs — PCA reaction

Thereafter, to take it to clinical application, the product was further standardized for relevant compliances to ensure that the endotoxin level is limited. It has also been certified for less than 100 ppm residual monomer content in purity testing.

Festigel has been applied in the following:

Human clinical studies

Urethral Stricture:

Buccal epithelium Expanded and Encapsulated in Scaffold‐Hybrid Approach to Urethral Stricture (BEES‐HAUS) procedure.

Vaddi SP, Reddy VB, Abraham SJ Buccal epithelium Expanded and Encapsulated in Scaffold-Hybrid Approach to Urethral Stricture (BEES-HAUS) procedure: A novel cell therapy-based pilot study. Int J Urol. 2019 Feb;26(2):253-257. doi: 10.1111/iju.13852.

Buccal Epithelium Hashed and Encapsulated in Scaffold – Hybrid Approach to Urethral Stricture (BHES-HAUS) Procedure

• Vaddi S, Senthilkumar R, Horiguchi A, Reddy DSK, Rajmohan M, Karthick R, Preethy S, Abraham SJK, et al. Comparative analysis of maximal urinary flow rate (Qmax) across different treatment modalities for male urethral stricture and its role as a predictor of long-term therapeutic outcome. Bladder. 2026:e21200086. doi:10.14440/bladder.0374.

• Horiguchi A, Vaddi S, Rajappa S, Preethy S, Abraham SJK BEES-HAUS preventing urethral stricture recurrence by restoring the integrity of urothelium and its further simplified version, the BHES-HAUS. Front Bioeng Biotechnol. 2025 Nov 27;13. doi: 10.3389/fbioe.2025.1687741.

• Vaddi S, Senthilkumar R, Reddy SK, Kumar CA, Shilpa P, Horiguchi A, Preethy S, Abraham SJK. Buccal Epithelium Hashed and Encapsulated in Scaffold–Hybrid Approach to Urethral Stricture (BHES-HAUS) - Preliminary Outcomes of Clinical Trial. Interactive Presentation. American Urological Association (AUA) Annual Meeting 2026; Washington, DC, USA. Abstract published in Journal of Urology [Internet]. 2026 May 1 [cited 2026 Apr 27];215(5S):e1312

Dr. Suryaprakash Vaddi presented the successful outcome of the BHES-HAUS clinical trial at the American Urological Association (AUA) 2026 Annual Meeting in Washington, DC, USA.

At 6 months follow-up, BHES-HAUS was 100% effective in providing a recurrence-free interval in patients with urethral stricture who had no prior intervention and in 73.3% of patients overall, including those who had undergone prior interventions such as DVIU and BMG urethroplasty.

The Festigel scaffold has been clinically applied as part of the BEES-HAUS procedure approved under the Act on Safety of Regenerative Medicine by the Government of Japan

Periodontal Bone regeneration:

Bone marrow mononuclear cells for periodontal bone regeneration.

Sankaranarayanan S, Jetty N, Gadagi JS, Preethy S, Abraham SJ. Periodontal regeneration by autologous bone marrow mononuclear cells embedded in a novel thermo reversible gelation polymer. J Stem Cells. 2013;8(2):99-103

Animal translational studies:

Cornea:

Sitalakshmi G, Sudha B, Madhavan HN, Vinay S, Krishnakumar S, Mori Y, Yoshioka H, Abraham S. Ex Vivo Cultivation of Corneal Limbal Epithelial Cells in a Thermoreversible Polymer (Mebiol Gel) and Their Transplantation in Rabbits: An Animal Model. Tissue Eng Part A. 2009 Feb;15(2):407-15. doi: 10.1089/ten.tea.2008.0041.

Liver regeneration:

Parveen N, Khan AA, Baskar S, Habeeb MA, Babu R, Abraham S, Yoshioka H, Mori Y, Mohammed HC. Intraperitoneal Transplantation of Hepatocytes Embedded in Thermoreversible Gelation Polymer (Mebiol Gel) in Acute Liver Failure Rat Model. Hepatitis Monthly 2008; 8(4): 275-280.

Cartilage regeneration:

Arumugam S, Bhupesh Karthik B, Rajeswar C, Mori Y, Yoshioka H, Senthilkumar R, Rajmohan M, Karthick R, Preethy S, Abraham S. Transplantation of autologous chondrocytes ex-vivo expanded using Thermoreversible Gelation Polymer in a rabbit model of articular cartilage defect. Journal of Orthopedics 2017: 14(2);223–25. doi: 10.1016/j.jor.2017.01.003

Spinal cord injury:

William JB, Prabakaran R, Ayyappan S Puskhinraj H, Rao D, Manjunath S , Thamaraikannan P, Dedeepiya V, Kuroda S, Yoshioka H, Mori Y, Preethy S, Abraham S. Functional Recovery of Spinal Cord Injury Following Application of Intralesional Bone Marrow Mononuclear Cells Embedded in Polymer Scaffold - Two Year Follow-up in a Canine. J Stem Cell Res Ther.2011; 1:110. doi:; Posted online on Nov 21, 2011. 10.4172/2157-7633.1000110

 

 

Publications on Festigel

• 17 May 2026: Vaddi S, Senthilkumar R, Reddy SK, Kumar CA, Shilpa P, Horiguchi A, Preethy S, Abraham SJK. Buccal Epithelium Hashed and Encapsulated in Scaffold–Hybrid Approach to Urethral Stricture (BHES-HAUS) - Preliminary Outcomes of Clinical Trial. Interactive Presentation. American Urological Association (AUA) Annual Meeting 2026; Washington, DC, USA. Abstract published in Journal of Urology [Internet]. 2026 May 1 [cited 2026 Apr 27];215(5S):e1312

• Horiguchi A, Kushibiki T, Mayumi Y, Shinchi M, Ojima K, Hirano Y, Katoh S, Iwasaki M, Abraham SJK, et al. A hybrid combination of in vitro cultured buccal mucosal cells using two different methodologies, complementing each other in successfully repairing a stricture-in.

• Parikumar P, Haraguchi K, Senthilkumar R, Abraham S. Human corneal endothelial cell transplantation with nanocomposite gel sheet preserves corneal stability in post-corneal transplant bullous keratopathy: a 16-year follow-up.Am J Stem Cells 2024;13(3):162-168. doi: 10.62347/CBYH7014

• Senthilkumar R, Yoshioka H, Katoh S, Iwasaki M, Surya Prakash V, Balamurugan M, Dedeepiya VD, Preethy S, Abraham. Engraftment and proliferation of thermoreversible-gelation-polymer-encapsulated human corneal limbal-stem-cells on ocular surface of a cadaver cornea. Current Eye Research.doi: 10.1080/02713683.2023.2180039.

• Horiguchi A, Shinchi M, Ojima K, Hirano Y, Kushibiki T, Mayumi Y, Miyai K, Miura I, Iwasaki M, Suryaprakash V, Senthilkumar R, Preethy S, Katoh S, Abraham SJK. Engraftment of Transplanted Buccal Epithelial Cells onto the Urethrotomy Site, Proven Immunohistochemically in Rabbit Model; a Feat to Prevent Urethral Stricture Recurrence.Stem Cell Rev Rep. 2022 Oct 28. doi: 10.1007/s12015-022-10466-1.

• Katoh S, Yoshioka H, Suzuki S, Nakajima H, Iwasaki M, Senthilkumar R, Preethy S, Abraham SJK An efficient polymer cocktail-based transportation method for cartilage tissue, yielding chondrocytes with enhanced hyaline cartilage expression during in vitro culturing. Journal of Orthopaedics 2022; 29(2022):60-64. https://doi.org/10.1016/j.jor.2022.01.007

• Horiguchi A, Ojima K, Shinchi M, Kushibiki T, Mayumi Y, Kushibiki T, Katoh S, Takeda M, Iwasaki M, Yoshioka H, Suryaprakash V, Balamurugan M, Senthilkumar R, Abraham SJK. In Vitro Culture Expansion and Characterization of Buccal Mucosal Epithelial Cells for Tissue Engineering Applications in Urethral Stricture After Transportation Using a Thermoreversible Gelation Biopreservation and Biobanking 2021. https://doi.org/10.1089/bio.2021.0079

• Katoh S, Fujimaru A, Iwasaki M, Yoshioka H, Senthilkumar R, Preethy S, Abraham SJK. Reversal of senescence-associated beta-galactosidase expression during in vitro three-dimensional tissue-engineering of human chondrocytes in a polymer scaffold. Scientific Reports 2021. Sci Rep 11, 14059 (2021) doi: 10.1038/s41598-021-93607-9.

• Horiguchi A, Ojima K, Shinchi M, Kushibiki T, Mayumi Y, Miyai K, Katoh S, Takeda M, Iwasaki M, Suryaprakash V, Balamurugan M, Rajmohan M, Preethy S, Abraham SJK. Successful engraftment of epithelial cells derived from autologous rabbit buccal mucosal tissue, encapsulated in a polymer scaffold in a rabbit model of a urethral stricture, transplanted using the transurethral approach. Regen. Ther. 2021; 18:127-132. doi: 10.1016/j.reth.2021.05.004.

• Katoh S, Yoshioka H, Senthilkumar R, Preethy S, Abraham S. Enhanced miRNA-140 expression of osteoarthritis-affected human chondrocytes cultured in a polymer based three-dimensional (3D) matrix. Life Sciences 2021. 119553. doi:10.1016/j.lfs.2021.119553.

• Katoh S, Rao KS, Suryaprakash V, Horiguchi A, Kushibiki T, Ojima K, Iwasaki M, Takeda M, Senthilkumar R, Rajmohan M, Karthick R, Preethy S, Abraham S. A 3D polymer scaffold platform for enhanced in vitro culture of Human & Rabbit buccal epithelial cells for cell therapies. Tokai J Exp Clin Med 2021; 46(1):1-6

• Namitha B, Chitra MR, Bhavya M, Katoh S, Yoshioka H, Iwasaki M, Senthilkumar R, Rajmohan M, Karthick R, Preethy S, Abraham SJK. A novel human donor cornea preservation cocktail incorporating a thermo-reversible gelation polymer (TGP), enhancing the corneal endothelial cell density maintenance and explant culture of corneal limbal cells.Biotechnology Letters 2021. doi:10.1007/s10529-021-03116-y

• Katoh S, Yoshioka H, Senthilkumar R, Preethy S, Abraham S. Enhanced expression of hyaluronic acid in osteoarthritis-affected knee-cartilage chondrocytes during three-dimensional in vitro culture in a hyaluronic-acid-retaining polymer scaffold.The Knee 2020; 29 : 365-73. doi:10.1016/j.knee.2021.02.019.

• Katoh S, Yoshioka H, Iwasaki M, Senthilkumar R, Rajmohan M, Karthick R, Preethy S, Abraham SJ. A three-dimensional in vitro culture environment of a novel polymer scaffold, yielding chondroprogenitors and mesenchymal stem cells in human chondrocytes derived from osteoarthritis-affected cartilage tissue. Journal of Orthopaedics 2021; 23 (2021):138-141. doi: 10.1016/j.jor.2021.01.005.

• Katoh S, Fujimaru A, Senthilkumar R, Preethy S, Abraham SJ. Articular chondrocytes from osteoarthritic knee joints of elderly, in vitro expanded in thermo-reversible gelation polymer (TGP), exhibiting higher UEA-1 expression in lectin microarray.Regen Ther. 2020;14:234-237. Published 2020 May 15. doi:10.1016/j.reth.2020.03.006

• Parikumar P, Haraguchi K, Senthilkumar R, Abraham SJ. Human corneal endothelial cell transplantation using nanocomposite gel sheet in bullous keratopathy.Am J Stem Cells. 2018 Feb 1;7(1):18-24|

• Arumugam S, Bhupesh Karthik B, Rajeswar C, Mori Y, Yoshioka H, Senthilkumar R, Rajmohan M, Karthick R, Preethy S, Abraham S. Transplantation of autologous chondrocytes ex-vivo expanded using Thermoreversible Gelation Polymer in a rabbit model of articular cartilage defectJournal of Orthopedics 2017: 14(2);223–25. doi: 10.1016/j.jor.2017.01.003

• Dedeepiya VD, William JB, Parthiban JKBC, Yoshioka H, Mori Y, Kuroda S, Iwasaki M, Preethy S, Abraham SJK. Scaffolds for Cell Transplantation in Neurology: The Suitability of a Thermoreversible Gelation Polymer—Our Perspectives.Journal of Spinal Surgery 2014;1(1). doi: JOSS/pdf/10.5005/jp-journals-10039-1003

• Parikumar P, Haraguchi K, Ohbayashi A, Senthilkumar R, Abraham S. Successful transplantation of in vitro expanded human cadaver corneal endothelial precursor cells on to a cadaver Bovine's eye using a Nanocomposite gel sheet.Curr Eye Res. 2014;39(5):522-6. doi:10.3109/02713683.2013.838633

• Rao S, Sudhakar J, Parikumar P, Natarajan S, Insaan A, Yoshioka H, Mori Y, Tsukahara S, Baskar S, Manjunath S, Senthilkumar R, Thamaraikannan P, Srinivasan T, Preethy S, Abraham S. Successful Transportation of Human Corneal Endothelial Tissues without Cool preservation in varying Indian Tropical climatic Conditions and in vitro Cell Expansion using a novel Polymer.Indian J Ophthalmol. 2014;62(2):130-5. doi: 10.4103/0301-4738.116457

• Krishnamohan J, Senthilnathan VS, Vaikundaraman TM, Srinivasan T, Balamurugan M, Iwasaki M, Preethy S , Abraham S. In vitro culture and characterization of enteric neural precursor cells from human gut biopsy specimens using polymer scaffold.Intractable Rare Dis Res. 2013 ;2(3):98-102.doi: 10.5582/irdr.2013.v2.3.98

• Senthilkumar R, Manjunath S, Baskar S, Dedeepiya DV, Natarajan S, John S, Parikumar P, Aditya I, Mori Y, Yoshioka H, Green DW, Balamurugan M, Tsukahara S, Abraham S. Successful Transportation and in vitro Expansion of Human Retinal Pigment Epithelium and its Characterization; a step towards Cell-based Therapy for Age related Macular Degeneration.Current Trends in Biotechnology and Pharmacy Jan 2012; Volume 6 (1): 44-54

• William JB, Prabakaran R, Ayyappan S Puskhinraj H, Rao D, Manjunath S , Thamaraikannan P, Dedeepiya V, Kuroda S, Yoshioka H, Mori Y, Preethy S, Abraham S. . Functional Recovery of Spinal Cord Injury Following Application of Intralesional Bone Marrow Mononuclear Cells Embedded in Polymer Scaffold - Two Year Follow-up in a Canine.. J Stem Cell Res Ther.2011; 1:110. doi:; Posted online on Nov 21, 2011. 10.4172/2157-7633.1000110

• Arumugam S, Manjunath S, Senthilkumar R, Srinivasan V, Rajendiran S, Yoshioka H, Mori Y, Samuel Abraham S. In vitro expansion and characterization of human chondrocytes using a novel Thermoreversible Gelation Polymer (TGP). J.Orthopaedics 2011;8(3)e3.

• Subrammaniyan R, Amalorpavanathan J, Shankar R, Rajkumar M, Baskar S, Manjunath SR, Senthilkumar R, Murugan P, Srinivasan VR, Abraham S. Application of autologous bone marrow mononuclear cells in six patients with advanced chronic critical limb ischemia as a result of diabetes: our experience. Cytotherapy. 2011 Sep;13(8):993-9. Epub 2011 Jun 15. doi: 10.3109/14653249.2011.579961

• Sitalakshmi G, Sudha B, Madhavan HN, Vinay S, Krishnakumar S, Mori Y, Yoshioka H, Abraham S. Ex Vivo Cultivation of Corneal Limbal Epithelial Cells in a Thermoreversible Polymer (Mebiol Gel) and Their Transplantation in Rabbits: An Animal Model. Tissue Eng Part A. 2009 Feb;15(2):407-15. doi: 10.1089/ten.tea.2008.0041.

• Parveen N, Khan AA, Baskar S, Habeeb MA, Babu R, Abraham S, Yoshioka H, Mori Y, Mohammed HC. Intraperitoneal Transplantation of Hepatocytes Embedded in Thermoreversible Gelation Polymer (Mebiol Gel) in Acute Liver Failure Rat Model.Hepatitis Monthly 2008; 8(4): 275-280.

• Sudha B, Madhavan HN, Sitalakshmi G, Malathi J, Krishnakumar S, Mori Y, Yoshioka H, Abraham S. Cultivation of human corneal limbal stem cells in Mebiol gel - A thermo-reversible gelation polymer.Indian J Med Res. 2006;124(6):655-64.

• Madhavan HN, Malathi J, Joseph PR, Mori Y, Abraham S, Yoshioka H. A study on the growth of continuous culture cell lines embedded in Mebiol Gel. Current Science, 87(9), 1275 - 1277 (2004)