Aneurysmal Bone Cyst
Conditions
Keywords
Aneurysmal bone cysts, PLGA, Platelet Lysate, Bone marrow, Mesenchymal stem cells
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.
Interventions
BIOLOGICALMSC-PLGA
Bone marrow derived MSC seeded on biodegradable PLGA, supplemented with PL.
Sponsors
Sophia Al-Adwan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 28 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment | 3 months | The safety of the engraftment will be monitored by assessing any adverse event resulting from the engraftment procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph | 6 months | Patients will be followed up radiographically to evaluate bone filling at the site of the ABC |
Countries
Jordan
Contacts
Primary ContactShayma Nazzal, Msc
Outcome results
None listed