Use of Stem Cells Cultured on a Scaffold for the Treatment of Aneurysmal Bone Cysts (ABC)

Sophia Al-Adwan

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Aneurysmal Bone Cyst

Treatments: Biological: MSC-PLGA

Study type: Interventional

Funder types: Other

Identifiers

NCT03066245

ABCUJCTC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 estimated patients

Sex: All

Ages: 4 to 28 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

MSC-PLGA

Experimental group

Description:

The lesion will be treated with curettage then 1 million of bone marrow derived MSC seeded on 5x5 mm2 PLGA scaffold will be engrafted in the cyst of ABC patient.

Treatment:

Biological: MSC-PLGA