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

South China Research Center for Stem Cell and Regenerative Medicine

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Fracture; Bone Nonunion

Treatments: Biological: Percutaneous; Biological: UCMSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT02815423

UCMSC-6

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

UCMSCs

Experimental group

Description:

Transplantation of umbilical cord mesenchymal stem cells (UCMSCs) in patients with fracture and bone nonunion.

Treatment:

Biological: UCMSCs

Placebo

Placebo Comparator group

Description:

The patients with fracture and bone nonunion who underwent percutaneous injection of placebo.

Treatment:

Biological: Percutaneous