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

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

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.

Study Overview

• Status: Unknown
• Conditions: Aneurysmal Bone Cyst
• Intervention / Treatment: Biological: MSC-PLGA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 4
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • Recruiting
    • Cell Therapy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 28 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MSC-PLGA; 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.	Biological: MSC-PLGA; Bone marrow derived MSC seeded on biodegradable PLGA, supplemented with PL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sophia Al-Adwan
• Investigators: Study Director: Abdalla Awidi, University of Jordan

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2018
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (ACTUAL): February 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Mesenchymal stem cells; Bone marrow; PLGA; Platelet Lysate; Aneurysmal bone cysts
• Additional Relevant MeSH Terms: Neoplasms; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Cysts; Bone Cysts; Bone Cysts, Aneurysmal
• Other Study ID Numbers: ABCUJCTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No