NCT04980261

Freeze-dried Bovine Hydroxyapatite/Secretome Composite for Bone Defects

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Dr. Soetomo General Hospital · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bone Loss

Interventions

Type	Name	Description
PROCEDURE	ORIF + autograft	Patients will undergo a standard open reduction internal fixation (ORIF) procedure with autograft implantation (from the iliac crest).
PROCEDURE	ORIF + FD BHA/Secretome	Patients will undergo an ORIF procedure and subsequently receive freeze-dried bovine hydroxyapatite/secretome composite implantation.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-07-01
• Completion: 2022-12-31
• First posted: 2021-07-28
• Last updated: 2021-07-28

Locations

1 site across 1 country: Indonesia