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Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation

NCT ID: NCT01207193

Last Updated: 2011-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Bone Cyst

Keywords

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bone cyst bone defect mesenchymal cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bone cyst

Patients with bone cyst defect are injected with mesenchymal cells.

Group Type EXPERIMENTAL

cell injection

Intervention Type BIOLOGICAL

injection of mesenchymal cells to bone cyst defect

Interventions

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cell injection

injection of mesenchymal cells to bone cyst defect

Intervention Type BIOLOGICAL

Other Intervention Names

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cell transplantation

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Royan Institute

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

President of Royan Institute

Mohammad reza Baghban Eslami Nejad, PhD

Role: STUDY_DIRECTOR

Scientific Board

Mohssen Emadeddin, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Investigator

Ahmad Vosough, MD

Role: STUDY_DIRECTOR

Radiologist investigator

Nasser Aghdami, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Head of regenerativ center

Locations

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Royan Institute

Tehran, , Iran

Site Status

Countries

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Iran

Related Links

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http://www.royaninstitute.org

Royan Institute

Other Identifiers

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Royan-Bone-005

Identifier Type: -

Identifier Source: org_study_id