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CompletedNCT01207193Updated Dec 14, 2011

Treatment Of Bone Cyst With Bone Marrow Mesenchymal Cell Transplantation

A Phase 1 interventional study of cell injection in Bone Cyst, sponsored by Royan Institute. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 12 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-14.

Sponsored by Royan Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
12 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bone Cyst

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Keywords

  • bone cyst bone defect mesenchymal cell
03

In context

Bone Cysts

18 studies on the registry are indexed under Bone Cysts; 5 are open to participants now.

This study's enrollment of 6 is below the median of 17 across 10 interventional studies indexed under Bone Cysts.

Browse Bone Cysts studies →

Lead sponsor

Royan Institute is the lead sponsor of 94 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with diagnosis of cancer
  • Patients enrolled in other clinical trial
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    bone cyst

    Patients with bone cyst defect are injected with mesenchymal cells.

    Biological: cell injection

Interventions

  • Biologicalcell injection

    injection of mesenchymal cells to bone cyst defect

    Also known as: cell transplantation

06

What researchers measure

Primary outcomes

  1. fulfill bone cyst defect

    Defect of bone due to cyst fulfill after cell transplantation.

    Time frame: 6 months

Secondary outcomes

  1. effect of mesenchymal cell transplantation

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

    Time frame: 6 months

07

Study locations

1 site
  • Royan Institute
    Tehran, Iran, Islamic Republic of
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01207193
Lead sponsor
Royan Institute
First posted
Sep 22, 2010
Start date
Oct 2009
Primary completion
Oct 2011
Completion
Dec 2011
Last update
Dec 14, 2011

Study contacts

Hamid Gourabi, PhD
study chair · President of Royan Institute
Mohammad reza Baghban Eslami Nejad, PhD
study director · Scientific Board
Mohssen Emadeddin, MD
principal investigator · Orthopedic Investigator
Ahmad Vosough, MD
study director · Radiologist investigator
Nasser Aghdami, MD,PhD
principal investigator · Head of regenerativ center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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