Clinical trial NCT02609074: Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
Official title: Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bone Fracture
Keywords: bone substitute
CPC
rhBMP-2
Lead sponsor: East China University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Shanghai 6th People's Hospital
name: Shanghai Zhongshan Hospital
First posted: 2015-11-20
Enrollment: 81
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The investigators initiated a pilot clinical study to test safety and preliminary efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and rehabilitation protocols.

Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been considered as the most perspective among all bone substitutes, yet little progress of its clinical translation has been made. The concept of "micro-scaffolds" was proposed in this study to provide a trajectory to its clinical translation.

Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further applied as an easy-to-operate filler for bone regeneration in a pilot clinical study. Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2 microffolds or traditional CPC paste (control group).

Detailed description: Objective: The investigators initiated a pilot clinical study to test safety and preliminary efficacy in humans (bone tissue repairing capacity) and to evaluate standard clinical and rehabilitation protocols.

Summary Background Data: Bone tissue engineering scaffolds loading growth factors have been considered as the most perspective among all bone substitutes, yet little progress of its clinical translation has been made. The concept of "micro-scaffolds" was proposed in this study to provide a trajectory to its clinical translation.

Methods: Pre-cured CPC/rhBMP-2 micro-scaffolds have been successfully developed and further applied as an easy-to-operate filler for bone regeneration in a pilot clinical study. Patients of tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a similar level of severity were randomly divided into two groups and treated by CPC/rhBMP-2 microffolds or traditional CPC paste (control group).

Eligibility criteria: Inclusion Criteria:

1. Age 16\~70 years.
2. Tibial plateau fractures, proximal humeral fractures, or calcaneal fractures at a similar level of severity.
3. An understanding of the rehabilitation protocol and willing to follow it.
4. An agreement to postoperative visits and tests.
5. Signed an informed subject consent form.

Exclusion Criteria:

-

Primary outcomes:
measure: X-ray
timeFrame: Pre-operation; 1, 2, 3, 4, 6, 8, 12, 18 and 24 months post-operation.
measure: Clinical examination
timeFrame: 1 week post-operation
Secondary outcomes:
measure: Function scoring - IOWA knee score
timeFrame: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
measure: Function scoring - IOWA ankle score
timeFrame: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
measure: Function scoring - NEER shoulder score
timeFrame: 1, 2, 3, 4, 6, 8 and 12 months post-operation.
Other outcomes:
Locations:
Study officials:
affiliation: Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology
name: Changsheng Liu, Ph.D.
role: STUDY_CHAIR
affiliation: Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology
name: Yuan Yuan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ninth People's Hospital of Shanghai Jiao Tong University
name: Jinwu Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: