Clinical Trial: Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Royan Institute

Current Primary Outcome: fulfill bone cyst defect [ Time Frame: 6 months ]

Defect of bone due to cyst fulfill after cell transplantation.


Original Primary Outcome: fullfill bone cyst defect [ Time Frame: 6 months ]

Defect of bone due to cyst fullfill after cell transplantation.


Current Secondary Outcome: effect of mesenchymal cell transplantation [ Time Frame: 6 months ]

Evaluate effect of mesenchymal cell transplantation to fulfill the defect of bone cyst.


Original Secondary Outcome: effect of mesenchymal cell transplantation [ Time Frame: 6 months ]

Evaluate effect of mesenchymal cell transplantation to fullfill the defect of bone cyst.


Information By: Royan Institute

Dates:
Date Received: September 21, 2010
Date Started: October 2009
Date Completion:
Last Updated: December 13, 2011
Last Verified: March 2009