Back to resultsSafety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
Primary Purpose
Fracture, Bone Nonunion
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
UCMSCs
Percutaneous
Sponsored by
About this trial
This is an interventional treatment trial for Fracture
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
UCMSCs
Placebo
Arm Description
Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.
The patients with fracture and bone nonunion who underwent percutaneous injection of placebo.
Outcomes
Primary Outcome Measures
Radiological progression of bone fusion
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
Comparison of the rate of complications between the 2 groups
Incidence of increased temperature sensitivity by questionnaire
Incidence and severity of infections at grafting sites by questionnaire
Full Information
NCT ID
NCT02815423
First Posted
April 20, 2016
Last Updated
June 23, 2016
Sponsor
South China Research Center for Stem Cell and Regenerative Medicine
Collaborators
Guangzhou Panyu Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02815423
Brief Title
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South China Research Center for Stem Cell and Regenerative Medicine
Collaborators
Guangzhou Panyu Central Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture, Bone Nonunion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UCMSCs
Arm Type
Experimental
Arm Description
Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients with fracture and bone nonunion who underwent percutaneous injection of placebo.
Intervention Type
Biological
Intervention Name(s)
UCMSCs
Intervention Description
Transplatation of umbilical cord mesenchymal stem cells
Intervention Type
Biological
Intervention Name(s)
Percutaneous
Intervention Description
Percutaneous injection
Primary Outcome Measure Information:
Title
Radiological progression of bone fusion
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Comparison of the rate of complications between the 2 groups
Time Frame
12 months
Title
Incidence of increased temperature sensitivity by questionnaire
Time Frame
6 months
Title
Incidence and severity of infections at grafting sites by questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuetao Pei, M.D., Ph.D
Phone
8610-68164807
Email
AMMS0906@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sihan Wang, Ph.D
Phone
8620-89199011
Email
wangsihan@scrm.org.cn
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
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