Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
NCT ID: NCT02140528
Last Updated: 2017-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2013-08-31
2016-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mesenchymal stem cell receipients
Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture.
Mesenchymal stem cell injection
Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
Placebo
Placebo injection in the site of fracture in patients with tibia fracture.
Placebo
Interventions
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Mesenchymal stem cell injection
Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The presence of tibial fracture based on X ray
* tibial fracture is limited to diaphysial
Exclusion Criteria
* Pregnancy
* liver or kidney disease or uncontrolled diabetes or heart and lung disease
* immune deficiency
18 Years
65 Years
ALL
No
Sponsors
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Royan Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Hamid Gourabi, PhD
Role: STUDY_CHAIR
Head of Royan Institute
Nasser Aghdami, MD,PhD
Role: STUDY_DIRECTOR
Head of regenerative medicine department &cell therapy center of Royan Institute
Mohsen Emaddedin, MD
Role: STUDY_DIRECTOR
Department or regenerative medicine of Royan Institute.
Aziz Ahmadi, MD
Role: PRINCIPAL_INVESTIGATOR
Scientific board of Iranian Orthopedic Association
Maedeh Ghorbani, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Regenerative Medicine
Afshin Farhadi, MD
Role: PRINCIPAL_INVESTIGATOR
Scientific board of Iranian Orthopedic Association
Locations
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Royan Institute
Tehran, , Iran
Countries
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Related Links
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Related Info
Other Identifiers
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Royan-Bone-012
Identifier Type: -
Identifier Source: org_study_id
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