Trial | NCT02140528  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
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 Started
Aug 31
2013
Primary Completion
Mar 31
2016
Study Completion
Apr 30
2016
Last Update
Apr 27
2017

Biological Mesenchymal stem cell injection

Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .

  • Other names: stem cell transplantation

Biological Placebo

Mesenchymal stem cell receipients Experimental

Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.

Placebo Placebo Comparator

Placebo injection in the site of fracture in patients with tibia fracture.

Criteria 

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
No Results Posted