NCT02140528

Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.

Detailed description

In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) . To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.

Conditions

• Tibial Fracture

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stem cell injection	Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
BIOLOGICAL	Placebo

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2014-05-16
• Last updated: 2017-04-27

Locations

1 site across 1 country: Iran