Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation
Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.
1 other identifier
interventional
6
1 country
1
Brief Summary
There are two types of bone cysts, unicameral and aneurismal. These cysts happen to anyone, but they are most commonly seen in children and young adults while their bones are still growing. Living with a bone cyst and determining treatment options depend on the type of cyst. Non-surgical treatments for unicameral bone cysts involves repeated X-rays in individuals who do not experience any symptoms. Surgical removal of a unicameral bone cyst is needed if it becomes especially painful, or the area of the bone starts to thin out. The investigators aim to assess the clinical efficacy and side effects of mesenchymal stem cells seeded on bone matrix in repairing bone cyst.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 21, 2010
CompletedFirst Posted
Study publicly available on registry
September 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 14, 2011
March 1, 2009
2 years
September 21, 2010
December 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fulfill bone cyst defect
Defect of bone due to cyst fulfill after cell transplantation.
6 months
Secondary Outcomes (1)
effect of mesenchymal cell transplantation
6 months
Study Arms (1)
bone cyst
EXPERIMENTALPatients with bone cyst defect are injected with mesenchymal cells.
Interventions
injection of mesenchymal cells to bone cyst defect
Eligibility Criteria
You may qualify if:
- Bone cyst diagnosed with MRI, CT-scan, or X-Ray
- Intact cyst wall with high risk for fracture
- Cysts with minimum diameter of 6mm
- Diagnostic test performed on cyst fluid
- Provided written consent form
You may not qualify if:
- Patients with diagnosis of cancer
- Patients enrolled in other clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Iran
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hamid Gourabi, PhD
President of Royan Institute
- STUDY DIRECTOR
Mohammad reza Baghban Eslami Nejad, PhD
Scientific Board
- PRINCIPAL INVESTIGATOR
Mohssen Emadeddin, MD
Orthopedic Investigator
- STUDY DIRECTOR
Ahmad Vosough, MD
Radiologist investigator
- PRINCIPAL INVESTIGATOR
Nasser Aghdami, MD,PhD
Head of regenerativ center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 21, 2010
First Posted
September 22, 2010
Study Start
October 1, 2009
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
December 14, 2011
Record last verified: 2009-03