Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2017
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJune 28, 2016
March 1, 2016
2 years
April 20, 2016
June 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (3)
Comparison of the rate of complications between the 2 groups
12 months
Incidence of increased temperature sensitivity by questionnaire
6 months
Incidence and severity of infections at grafting sites by questionnaire
6 months
Study Arms (2)
UCMSCs
EXPERIMENTALTransplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.
Placebo
PLACEBO COMPARATORThe patients with fracture and bone nonunion who underwent percutaneous injection of placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2016
First Posted
June 28, 2016
Study Start
January 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
June 28, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share