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Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation

Primary Purpose

Bone Cyst

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

cell injection

About this trial

This is an interventional treatment trial for Bone Cyst focused on measuring bone cyst bone defect mesenchymal cell

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bone cyst

Arm Description

Patients with bone cyst defect are injected with mesenchymal cells.

Outcomes

Primary Outcome Measures

fulfill bone cyst defect

Defect of bone due to cyst fulfill after cell transplantation.

Secondary Outcome Measures

effect of mesenchymal cell transplantation

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

Full Information

NCT ID

NCT01207193

First Posted

September 21, 2010

Last Updated

December 13, 2011

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT01207193

Brief Title

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

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Cyst

Keywords

bone cyst bone defect mesenchymal cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bone cyst

Arm Type

Experimental

Arm Description

Patients with bone cyst defect are injected with mesenchymal cells.

Intervention Type

Biological

Intervention Name(s)

cell injection

Other Intervention Name(s)

cell transplantation

Intervention Description

injection of mesenchymal cells to bone cyst defect

Primary Outcome Measure Information:

Title

fulfill bone cyst defect

Description

Defect of bone due to cyst fulfill after cell transplantation.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

effect of mesenchymal cell transplantation

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials: