Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion

Phase 1

• Conditions: Bone Nonunion; Fracture
• Interventions: Biological: Percutaneous; Biological: UCMSCs

• Registration Number: NCT02815423
• Lead Sponsor: South China Research Center for Stem Cell and Regenerative Medicine

Brief Summary

The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-06-23
• Last Update Submitted: 2016-06-23
• Study First Posted: 2016-06-28
• Last Update Posted: 2016-06-28
• Study Start: 2017-01
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Every patient with non union in the site of bone fracture and nonunion.
• Age more than 18 and less than 60 years old.
• Nonunion or delayed union.

Exclusion Criteria

• Diagnosis of cancer.
• Pregnancy or breastfeeding.
• Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing.
• Any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial.
• Patients do not sign the consent forms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Percutaneous	The patients with fracture and bone nonunion who underwent percutaneous injection of placebo.
UCMSCs	UCMSCs	Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.

Primary Outcome Measures

Name	Time	Method
Radiological progression of bone fusion	12 months	After patients receiving mesenchymal stem cells or placebo, imaging control by X-ray and CT, and then analysis by software(ImageJ ) at 1, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of infections at grafting sites by questionnaire	6 months
Comparison of the rate of complications between the 2 groups	12 months
Incidence of increased temperature sensitivity by questionnaire	6 months