Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
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|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|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|