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Industrial Research And Consultancy Centre
Patent
A Composite Scaffold and a Method for its Preparation
Abstract

The technology introduces a bioactive scaffold, a composite of anionic charged sodium salt of Carboxymethyl chitin and Gelatin (CMChNa-GEL) reinforced with hydroxyapatite nanocrystals (nHA). This scaffold is engineered to enhance stem cell growth and bone mineralization, offering a significant advance in tissue engineering and regenerative medicine.

Figure (1) Flow chart illustrating reaction steps for nano-hydroxyapatite (n-HA) preparation; (2)(a) Subcutaneous tissue and periosteum separated gently from cortical bone, and (b) The immediate hemostasis observed at the defect site after application of n-HA/gel/CMC scaffold construct, could helped in the formation of fibrin rich platform which thus, initiated spontaneous healing; (3) Gross observations of defect site after week 25 (a) treated with n-HA/gel/CMC with adherent soft tissue, (b) after removal of soft tissue, showed ultimate scar-free closure of the cortical window and (c) of SHAM operated site.

Problem Statement

Current bone grafting techniques such as autografts and allografts suffer from limitations including limited availability, donor site morbidity, and risks of immune rejection or disease transmission. Synthetic grafts, particularly single-phase ceramics or powdered composites, either lack mechanical resilience or biocompatibility. There is a critical need for a 3D scaffold that is both structurally stable and bioactive, capable of supporting stem cell growth, osteointegration, and bone regeneration4particularly for large or irregular defects4 without the use of growth factors.

Uniqueness of the Solution
  • Elastic Scaffold Composite: Combines nano-hydroxyapatite with carboxymethyl chitin and gelatin to form a sponge-like elastic 3D scaffold. 
  • Xeno-Free & Feeder-Free Platform: First scaffold to support human embryonic stem cells without animal-derived components or feeder cells. 
  • Mechanical Compatibility with Native Bone: Offers tunable elasticity and resilience, allowing easy fitting into defects without breakage or inflammation. 
  • Bio-Mimetic Integration: Promotes natural bone-like mineralization and supports contact-guided tissue ingrowth and regeneration.
Prototype Details

The prototype scaffold was synthesized by solvent casting, glutaraldehyde vapor crosslinking, and freeze-drying. It uses an optimized blend of 0.5g nano-hydroxyapatite, 0.5g CMChNa, and 1g gelatin. The scaffold has a uniform porous structure with pore sizes around 150 µm, is elastic with shape-memory recovery, and shows 39% nHA content. Biological validation includes cell studies with MG63 osteoblast-like cells and NT2/D1 stem cells, SBF mineralization tests, platelet adhesion studies, and in vivo rabbit defect healing assessments.

Current Status of Technology

The composite scaffold has been successfully developed at lab scale and validated through pre-clinical studies using rabbit tibia models. Detailed histological, micro-CT, and in vitro cell culture evaluations (with MG63 and NT2/D1 cells) demonstrate its efficacy in promoting bone growth, stem cell attachment, and biomineralization. The scaffold has also undergone material characterization via FTIR, XRD, SEM, TEM, AFM, and TGA.

Technology readiness level

5

Societal Impact

This scaffold offers a biocompatible, xeno-free, and elastic alternative to conventional bone grafts, avoiding issues like inflammation, surgical complications, and dependence on donor grafts. It empowers surgeons with a moldable, regenerative material that improves healing outcomes, reduces need for repeat surgeries, and potentially lowers treatment costs. With its ability to support embryonic stem cell growth, it also advances the field of regenerative medicine and stem cell therapies.

Applications or Domain
  • Maxillofacial and Dental Surgery: For repair and regeneration in facial bone defects and dental implants. 
  • Orthopedic Implants: Suitable for treating critical bone defects and fractures in load-bearing bones. 
  • Stem Cell Research Platforms: Supports feeder-free culture and renewal of embryonic stem cells. 
  • Oncological Bone Repair: Ideal for reconstructing bone post-tumor resection due to biocompatibility and flexibility.

Geography of IP

Type of IP

Application Number

1592/MUM/2015

Filing Date
Grant Number

407936

Grant Date
Assignee(s)
Indian Institute of Technology Bombay
**This IP is owned by IIT Bombay**