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

Aneurysmal Bone Cyst Clinical Trial

Official title:

Autologous Bone Tissue Constructed On Biodegradable Polymer for the Treatment of Aneurysmal Bone Cysts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03066245
• Other study ID #: ABCUJCTC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 3, 2018
• Est. completion date: March 2020

Study information

• Verified date: July 2019
• Source: University of Jordan
• Contact: Shayma Nazzal, Msc
• Phone: 00962795770585
• Email: shayma20585[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Bone Cyst
• Bone Cysts
• Cysts

Intervention

Biological:
• MSC-PLGA
Bone marrow derived MSC seeded on biodegradable PLGA, supplemented with PL.

Locations

Country	Name	City	State
Jordan	Cell Therapy Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Sophia Al-Adwan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment	The safety of the engraftment will be monitored by assessing any adverse event resulting from the engraftment procedure	3 months
Secondary	Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph	Patients will be followed up radiographically to evaluate bone filling at the site of the ABC	6 months