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Trial record 83 of 222 for:    umbilical cord mesenchymal stem cells
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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

Tracking Information
First Submitted Date  ICMJE April 20, 2016
First Posted Date  ICMJE June 28, 2016
Last Update Posted Date June 28, 2016
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Comparison of the rate of complications between the 2 groups [ Time Frame: 12 months ]
  • Incidence of increased temperature sensitivity by questionnaire [ Time Frame: 6 months ]
  • Incidence and severity of infections at grafting sites by questionnaire [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Fracture
  • Bone Nonunion
Intervention  ICMJE
  • Biological: UCMSCs
    Transplatation of umbilical cord mesenchymal stem cells
  • Biological: Percutaneous
    Percutaneous injection
Study Arms  ICMJE
  • Experimental: UCMSCs
    Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.
    Intervention: Biological: UCMSCs
  • Placebo Comparator: Placebo
    The patients with fracture and bone nonunion who underwent percutaneous injection of placebo.
    Intervention: Biological: Percutaneous
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2016)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xuetao Pei, M.D., Ph.D 8610-68164807 AMMS0906@163.com
Contact: Sihan Wang, Ph.D 8620-89199011 wangsihan@scrm.org.cn
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02815423
Other Study ID Numbers  ICMJE UCMSC-6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party South China Research Center for Stem Cell and Regenerative Medicine
Study Sponsor  ICMJE South China Research Center for Stem Cell and Regenerative Medicine
Collaborators  ICMJE Guangzhou Panyu Central Hospital
Investigators  ICMJE Not Provided
PRS Account South China Research Center for Stem Cell and Regenerative Medicine
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP