Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
|ClinicalTrials.gov Identifier: NCT02140528|
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tibial Fracture||Biological: Mesenchymal stem cell injection Biological: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Mesenchymal stem cell receipients
Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.
Biological: Mesenchymal stem cell injection
Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
Other Name: stem cell transplantation
Placebo Comparator: Placebo
Placebo injection in the site of fracture in patients with tibia fracture.
- Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140528
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Hamid Gourabi, PhD||Head of Royan Institute|
|Study Director:||Nasser Aghdami, MD,PhD||Head of regenerative medicine department &cell therapy center of Royan Institute|
|Study Director:||Mohsen Emaddedin, MD||Department or regenerative medicine of Royan Institute.|
|Principal Investigator:||Aziz Ahmadi, MD||Scientific board of Iranian Orthopedic Association|
|Principal Investigator:||Maedeh Ghorbani, MD||Department of Regenerative Medicine|
|Principal Investigator:||Afshin Farhadi, MD||Scientific board of Iranian Orthopedic Association|