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Freeze-dried Bovine Hydroxyapatite/Secretome Composite for Bone Defects

Bone Loss Clinical Trial

Official title:
Clinical Trial of Freeze-dried Bovine Hydroxyapatite/Secretome Composite Application for the Management of Long Bone Defects in the Lower Extremities

Clinical Trial Summary

This clinical trial aims to investigate the efficacy of freeze-dried bovine hydroxyapatite/secretome composite application for the management of long bone defects and other bone healing disorders in the lower extremities.

Clinical Trial Description

The gold standard for treating bone defect conditions is autologous bone graft (autograft). Autograft promotes bone healing due to its osteoconductive (serving as a foundation that facilitates bone growth), osteoinductive (stimulates progenitor cells), and osteogenesis (acting as a precursor of osteoblasts and osteoclasts) properties. However, donor site morbidity and persisting pain following harvest remains a major problem. Hence, we attempt to investigate the efficacy of other bone substitutes, i.e., bovine hydroxyapatite/secretome composite, to treat long bone defects and other bone healing disorders in the lower extremities. Bovine hydroxyapatite (BHA) is a xenograft (animal-derived graft) with osteoconductive properties. Simultaneously, the secretome of the mesenchymal stem cells contains cytokines, chemokines, and growth factors, which possess osteoinductive properties. Thus, we hypothesize that the combination (composite) of BHA/secretome (in the form of freeze-dried (FD) BHA/secretome composite) will promote bone healing ability that is equal to autografts while eliminating donor-site morbidity in the patient. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04980261
Study type Interventional
Source Dr. Soetomo General Hospital
Contact Ferdiansyah Mahyudin, MD, Ph.D
Phone +62811320635
Email ferdyortho@yahoo.com
Status Recruiting
Phase N/A
Start date July 1, 2020
Completion date December 31, 2022
View Details
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