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

NCT ID: NCT02815423

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Fracture Bone Nonunion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UCMSCs

Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.

Group Type EXPERIMENTAL

UCMSCs

Intervention Type BIOLOGICAL

Transplatation of umbilical cord mesenchymal stem cells

Placebo

The patients with fracture and bone nonunion who underwent percutaneous injection of placebo.

Group Type PLACEBO_COMPARATOR

Percutaneous

Intervention Type BIOLOGICAL

Percutaneous injection

Interventions

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UCMSCs

Transplatation of umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

Percutaneous

Percutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Panyu Central Hospital

OTHER

Sponsor Role collaborator

South China Research Center for Stem Cell and Regenerative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Xuetao Pei, M.D., Ph.D

Role: CONTACT

8610-68164807

Sihan Wang, Ph.D

Role: CONTACT

8620-89199011

Other Identifiers

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UCMSC-6

Identifier Type: -

Identifier Source: org_study_id

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