Use of Stem Cells Cultured on a Scaffold for the Treatmen... | NCT03066245

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

NCT03066245

Sponsor

Sophia Al-Adwan

Status

Unknown status

Last Update Posted

Jul 24, 2019Actual

Enrollment

4Estimated

Phase

Phase 1Phase 2

Conditions

Aneurysmal Bone Cyst

Interventions

MSC-PLGA

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 3, 2018Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Feb 23, 2017

First Submission Date that Met QC Criteria

Feb 27, 2017

First Posted Date

Feb 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2019

Last Update Posted Date

Jul 24, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sophia Al-Adwan, Researcher, Msc, University of JordanSponsor-Investigator

Lead Sponsor

Sophia Al-AdwanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSC-PLGA	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MSC-PLGA	Biological	Bone marrow derived MSC seeded on biodegradable PLGA, supplemented with PL.	MSC-PLGA

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

28 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shayma Nazzal, Msc	Contact	00962795770585		shayma20585@gmail.com

Overall Officials

Name	Affiliation	Role
Abdalla Awidi	University of Jordan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cell Therapy Center	Recruiting	Amman		11942	Jordan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017824	Bone Cysts, Aneurysmal

Ancestor Terms

ID	Term
D001845	Bone Cysts
D003560	Cysts
D009369	Neoplasms
D001847	Bone Diseases
D009140

Browse Leaves

Not provided

Browse Branches

Not provided