Clinical trial NCT01207193: Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation
Official title: Effect of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Reconstructing Bone Defects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bone Cyst
Keywords: bone cyst bone defect mesenchymal cell
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2010-09-22
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: fulfill bone cyst defect
timeFrame: 6 months
Secondary outcomes:
measure: effect of mesenchymal cell transplantation
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: President of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Scientific Board
name: Mohammad reza Baghban Eslami Nejad, PhD
role: STUDY_DIRECTOR
affiliation: Orthopedic Investigator
name: Mohssen Emadeddin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiologist investigator
name: Ahmad Vosough, MD
role: STUDY_DIRECTOR
affiliation: Head of regenerativ center
name: Nasser Aghdami, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: