Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Phase 2

Completed

• Conditions: Tibial Fracture

• Registration Number: NCT02140528
• Lead Sponsor: Royan Institute

Brief 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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-16
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18 to 65 years
• The presence of tibial fracture based on X ray
• tibial fracture is limited to diaphysial

Exclusion Criteria

• Addiction
• Pregnancy
• liver or kidney disease or uncontrolled diabetes or heart and lung disease
• immune deficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group	6 months

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of