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

Last updated: July 23, 2019
Sponsor: Sophia Al-Adwan
Overall Status: Active - Recruiting

Phase

1/2

Condition

Bone Neoplasm

Treatment

N/A

Clinical Study ID

NCT03066245
ABCUJCTC
  • Ages 4-28
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ;suchas allograft failed or who are not candidate of autografts

  • Provided written consent form

Exclusion

Exclusion Criteria:

  • Patients with diagnosis of cancer

  • Patients enrolled in other clinical trial

Study Design

Total Participants: 4
Study Start date:
May 03, 2018
Estimated Completion Date:
March 31, 2020

Study 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.

Connect with a study center

  • Cell Therapy Center

    Amman, 11942
    Jordan

    Active - Recruiting

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