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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03066245 |
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Date of registration:
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23/02/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Use of Stem Cells Cultured on a Scaffold for the Treatment of Aneurysmal Bone Cysts (ABC)
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Scientific title:
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Autologous Bone Tissue Constructed On Biodegradable Polymer for the Treatment of Aneurysmal Bone Cysts |
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Date of first enrolment:
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May 3, 2018 |
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Target sample size:
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4 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03066245 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Shayma Nazzal, Msc |
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Address:
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Telephone:
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00962795770585 |
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Email:
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shayma20585@gmail.com |
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Affiliation:
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Name:
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Abdalla Awidi, MD |
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Address:
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Telephone:
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0096265355000 |
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Email:
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abdalla.awidi@gmail.com |
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Affiliation:
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Name:
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Abdalla Awidi |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Jordan |
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Key inclusion & exclusion 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
- Diagnosed ABC patients whom treatments with other forms of classical therapies ;such
as allograft failed or who are not candidate of autografts
- Provided written consent form
Exclusion Criteria:
- Patients with diagnosis of cancer
- Patients enrolled in other clinical trial
Age minimum:
4 Years
Age maximum:
28 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aneurysmal Bone Cyst
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Intervention(s)
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Biological: MSC-PLGA
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Primary Outcome(s)
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment
[Time Frame: 3 months]
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Secondary Outcome(s)
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Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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