Clinical trial NCT04980261: Freeze-dried Bovine Hydroxyapatite/Secretome Composite for Bone Defects
Official title: Clinical Trial of Freeze-dried Bovine Hydroxyapatite/Secretome Composite Application for the Management of Long Bone Defects in the Lower Extremities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Loss
Keywords: Bone Defects
Bone Substitutes
Hydroxyapatites
Mesenchymal Stem Cells
Secretome
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Dr. Ramelan Naval Hospital
name: Airlangga University Hospital
name: Sidoarjo General Hospital
name: Cell & Tissue Bank, Dr. Soetomo General Hospital
First posted: 2021-07-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with bone defects (less than 5 cm) in the diaphysis of the long bones of the lower extremities due to trauma and other bone healing disorders
* No history of comorbid diseases
* Willing to be involved in the clinical trial

Exclusion Criteria:

* Patients with bone defects or impaired bone healing caused by tumors, infections, and metabolic diseases
* Suffered from multiple fractures and multitrauma patients
* Loss to follow-up

Primary outcomes:
measure: X-ray evaluation immediately following surgery.
timeFrame: Day-0
measure: X-ray evaluation at 4 weeks following surgery
timeFrame: 4 weeks
measure: X-ray evaluation at 8 weeks following surgery.
timeFrame: 8 weeks
measure: X-ray evaluation at 12 weeks following surgery.
timeFrame: 12 weeks
measure: X-ray evaluation at 16 weeks following surgery.
timeFrame: 16 weeks
measure: Ultrasonography evaluation at 2 weeks
timeFrame: 2 weeks
measure: Ultrasonography evaluation at 4 weeks
timeFrame: 4 weeks
measure: Ultrasonography evaluation at 8 weeks
timeFrame: 8 weeks
measure: Ultrasonography evaluation at 12 weeks
timeFrame: 12 weeks
measure: Ultrasonography evaluation at 16 weeks
timeFrame: 16 weeks
Secondary outcomes:
measure: Functional evaluation at 8 weeks following surgery.
timeFrame: 8 weeks
measure: Functional evaluation at 12 weeks following surgery.
timeFrame: 12 weeks
measure: Functional evaluation at 16 weeks following surgery.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Hospital
state: East Java
Study officials:
References: