Pilot Clinical Trial of CPC/rhBMP-2 Microffolds as Bone Substitute for Bone Regeneration

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).

Conditions

• Bone Fracture

Interventions

PROCEDURE

Minimally invasive internal fixation surgeries

DEVICE

CPC/rhBMP-2 micro-scaffolds

DEVICE

CPC paste

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  collaborator OTHER

• Shanghai 6th People's Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• East China University of Science and Technology

  lead OTHER

Principal Investigators

• Changsheng Liu, Ph.D. · Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology

• Yuan Yuan, Ph.D. · Engineering Research Center for Biomaterials of Ministry of Education, East China University of Science and Technology

• Jinwu Wang, Ph.D. · Ninth People's Hospital of Shanghai Jiao Tong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-31

Primary Completion

2015-06-30

Completion

2015-10-31