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

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ClinicalTrials.gov Identifier: NCT02815423
Recruitment Status : Not yet recruiting
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Collaborator:
Guangzhou Panyu Central Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fracture Bone Nonunion Biological: UCMSCs Biological: Percutaneous Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: UCMSCs
Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.
Biological: UCMSCs
Transplatation of umbilical cord mesenchymal stem cells

Placebo Comparator: Placebo
The patients with fracture and bone nonunion who underwent percutaneous injection of placebo.
Biological: Percutaneous
Percutaneous injection




Primary Outcome Measures :
  1. Radiological progression of bone fusion [ Time Frame: 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 :
  1. Comparison of the rate of complications between the 2 groups [ Time Frame: 12 months ]
  2. Incidence of increased temperature sensitivity by questionnaire [ Time Frame: 6 months ]
  3. Incidence and severity of infections at grafting sites by questionnaire [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815423


Contacts
Contact: Xuetao Pei, M.D., Ph.D 8610-68164807 AMMS0906@163.com
Contact: Sihan Wang, Ph.D 8620-89199011 wangsihan@scrm.org.cn

Sponsors and Collaborators
South China Research Center for Stem Cell and Regenerative Medicine
Guangzhou Panyu Central Hospital

Responsible Party: South China Research Center for Stem Cell and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT02815423     History of Changes
Other Study ID Numbers: UCMSC-6
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries