Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Royan Institute
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- fulfill bone cyst defect
Study Overview
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.
Detailed Description
Bone cysts are benign lesions usually discovered in children from age of 5 to 15 years. Treatment options include observation, corticosteroid injection and surgery. Sometimes the risk of surgery is comparable to the likelihood of fracture without treatment. In orthopedic surgery, bone chips , various types of ceramics, natural and synthetized bone mineral hydroxyapatite and tricalcium phosphate, as well as numerous polymers and co-polymers of alfa-hydroxy acids are used to perform as an osteoconductive and rarely osteoinductive factor to help bone formation.Some evidence demonstrated that bone marrow mesenchymal stem cells deposited on the surface of this constructs enhance its osteogenic differentiation. In this study the investigators seeds cultured bone marrow derived mesenchymal stem cells on bone matrix, to evaluate its therapeutic potential in repairing unicameral or aneurysmal bone cyst.This composite is placed in the bone cyst after its curettage during a surgery.Post-operation assessment is done by X-Ray examination and MRI at 1, 2, 6, and 12 months after treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients with diagnosis of cancer
- •Patients enrolled in other clinical trial
Outcomes
Primary Outcomes
fulfill bone cyst defect
Time Frame: 6 months
Defect of bone due to cyst fulfill after cell transplantation.
Secondary Outcomes
- effect of mesenchymal cell transplantation(6 months)