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

Sponsor

Sophia Al-Adwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT03066245

Collaborator

(none)

Enrollment

Location

Arm

21.9

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Bone Cyst	Biological: MSC-PLGA	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

4 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 3, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the MSC-PLGA engraftment [3 months]
The safety of the engraftment will be monitored by assessing any adverse event resulting from the engraftment procedure

Secondary Outcome Measures

Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph [6 months]
Patients will be followed up radiographically to evaluate bone filling at the site of the ABC

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 28 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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