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Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.


Phase 1
12 Years
75 Years
Not Enrolling
Both
Bone Cyst

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Trial Information

Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

fulfill bone cyst defect

Outcome Description:

Defect of bone due to cyst fulfill after cell transplantation.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Hamid Gourabi, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

President of Royan Institute

Authority:

Iran: Ethics Committee

Study ID:

Royan-Bone-005

NCT ID:

NCT01207193

Start Date:

October 2009

Completion Date:

December 2011

Related Keywords:

  • Bone Cyst
  • bone cyst bone defect mesenchymal cell
  • Bone Cysts
  • Cysts

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