Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.|
- fulfill bone cyst defect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Defect of bone due to cyst fulfill after cell transplantation.
- effect of mesenchymal cell transplantation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Evaluate effect of mesenchymal cell transplantation to fulfill the defect of bone cyst.
|Study Start Date:||October 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: bone cyst
Patients with bone cyst defect are injected with mesenchymal cells.
Biological: cell injection
injection of mesenchymal cells to bone cyst defect
Other Name: cell transplantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207193
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|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|