Clinical study on custom-made bone implants alpha-TCP-based novel bone implants with geometry that fits bone defects and internal structures efficient for bone tissue regeneration

UMIN ID: UMIN000000605

Registered date:09/02/2007

Basic Information

• Health condition(s) or Problem(s) studied: Congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks
• Date of first enrollment: 2006/03/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Artificial bones molded by ink-jet printing techniques are implanted to congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks

Outcome(s)

• Primary Outcome: Confirmation of safety and efficacy of custom-made bone implants (3DB-01)

Key inclusion & exclusion criteria

• Age minimum: 6years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with complications including abnormal calcium metabolism or serious cardiac, hepatic or renal dysfunctions (grade 2 and grade 3 in the complication category) 2) Patients who have less-than-one-year prognoses of complications 3) Patients with severe complications who are not expected to endure tests necessary for clinical follow-up. 4) Patients with infections that may relapse. 5) Patients with collagen diseases. 6) Patients with histories of alcohol or drug dependency within the past 3 months 7) Patients with malignant neoplasms 8) Patients with possibile malignant neoplasms 9) Patients with proliferative diabetic retinopathy 10) Pregnant women, women suspected of being pregnant and breast-feeding women 11) Patients who cannot observe the instruction not to inflict excessive forces and burdens on affected areas after implantation and patients with mental disorders. 12) Patients who do not give informed consents 13) Patients who are judged to be inappropriate for the study by doctors in charge.

Related Information

• Primary Sponsor: The University of Tokyo Hospital Division of Tissue Engineering
• Source(s) of Monetary Support: Funding for Development of Highly-advanced Medical Technology