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

NCT ID: NCT03066245

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2020-03-31

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 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.

Conditions

Aneurysmal Bone Cyst

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MSC-PLGA

Intervention Type: BIOLOGICAL

Bone marrow derived MSC seeded on biodegradable PLGA, supplemented with PL.

Interventions

MSC-PLGA

Bone marrow derived MSC seeded on biodegradable PLGA, supplemented with PL.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sophia Al-Adwan

OTHER

Sponsor Role: lead

Responsible Party

Sophia Al-Adwan

Researcher, Msc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Abdalla Awidi

Role: STUDY_DIRECTOR

University of Jordan

Locations

Cell Therapy Center

Amman, , Jordan

Site Status: RECRUITING

Countries

Jordan

Central Contacts

Shayma Nazzal, Msc

Role: CONTACT

shayma20585@gmail.com

00962795770585

Facility Contacts

Abdalla Awidi, MD

Role: primary

abdalla.awidi@gmail.com

0096265355000 ext. 23960

Other Identifiers

ABCUJCTC

Identifier Type: -

Identifier Source: org_study_id