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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Sophia Al-Adwan

Current Primary Outcome: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment [ Time Frame: 3 months ]

The safety of the engraftment will be monitored by assessing any adverse event resulting from the engraftment procedure


Original Primary Outcome: Same as current

Current Secondary Outcome: Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph [ Time Frame: 6 months ]

Patients will be followed up radiographically to evaluate bone filling at the site of the ABC


Original Secondary Outcome: Same as current

Information By: University of Jordan

Dates:
Date Received: February 23, 2017
Date Started: October 3, 2016
Date Completion: July 15, 2019
Last Updated: February 27, 2017
Last Verified: February 2017