Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation

Bone Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207193
• Other study ID #: Royan-Bone-005
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2010
• Last updated: December 13, 2011
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2009
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bone Cyst
• Bone Cysts

Intervention

Biological:
• cell injection
injection of mesenchymal cells to bone cyst defect

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fulfill bone cyst defect	Defect of bone due to cyst fulfill after cell transplantation.	6 months	Yes
Secondary	effect of mesenchymal cell transplantation	Evaluate effect of mesenchymal cell transplantation to fulfill the defect of bone cyst.	6 months	Yes

External Links

•   Royan Institute