Clinical trial NCT03066245: Use of Stem Cells Cultured on a Scaffold for the Treatment of Aneurysmal Bone Cysts (ABC)
Official title: Autologous Bone Tissue Constructed On Biodegradable Polymer for the Treatment of Aneurysmal Bone Cysts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Aneurysmal Bone Cyst
Keywords: Aneurysmal bone cysts
PLGA
Platelet Lysate
Bone marrow
Mesenchymal stem cells
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 4
Sex: ALL
Minimum age (years): 4
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients qualified for this study are those diagnosed with ABCs and failed to be treated with other forms of classical therapies. In which, these patients will be engrafted with biodegradable scaffolds seeded with Mesenchymal Stem Cells (MSCs) supplemented with Platelet lysate.

Detailed description: Aneurysmal bone cysts (ABC) are relatively rare, benign, tumor-like, expansile osteolytic lesions of unknown etiology which are predominantly found within the long bones and characterized by frequent idiopathic fractures. Despite the large variety of bone substitutes that have been used to fill these cystic lesions, to date there is no graft material which can be regarded as completely satisfactory, with a recurrence rate that ranges from 5-40% of treated cases. Autologous bone marrow derived mononuclear cells have been used previously to treat ABCs. Poly lactic-co-glycolic acid (PLGA) scaffolds have been used in bone tissue engineering due to their biodegradability and biocompatibility. Human platelet lysate (PL) contains a number of mitogenic growth factors and has been demonstrated to enhance mesenchymal stem cell (MSC) proliferation and expansion rate in vitro. This study is designed to assess the safety and effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs and supplemented with osteogenic media and platelet lysate in healing bone lesions of patients suffering from aneurysmal bone cysts. This study will be conducted at the Cell Therapy Center (CTC), Jordan. Four ABC cases will be included. Patients qualified for this study are those diagnosed with ABCs and failed to be treated with other forms of classical therapies; such as allografts or who are not candidate of autografts.

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
* 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment
timeFrame: 3 months
Secondary outcomes:
measure: Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph
timeFrame: 6 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: University of Jordan
name: Abdalla Awidi
role: STUDY_DIRECTOR
References: