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

Fracture Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02815423
• Other study ID #: UCMSC-6
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: April 20, 2016
• Last updated: June 23, 2016
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: March 2016
• Source: South China Research Center for Stem Cell and Regenerative Medicine
• Contact: Xuetao Pei, M.D., Ph.D
• Phone: 8610-68164807
• Email: AMMS0906[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Nonunion
• Fracture

Intervention

Biological:
• UCMSCs
Transplatation of umbilical cord mesenchymal stem cells
• Percutaneous
Percutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
South China Research Center for Stem Cell and Regenerative Medicine	Guangzhou Panyu Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparison of the rate of complications between the 2 groups		12 months	No
Secondary	Incidence of increased temperature sensitivity by questionnaire		6 months	No
Secondary	Incidence and severity of infections at grafting sites by questionnaire		6 months	Yes