NCT03066245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 3, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

1.6 years

First QC Date

February 23, 2017

Last Update Submit

July 23, 2019

Conditions

Aneurysmal Bone Cyst

Keywords

Aneurysmal bone cystsPLGAPlatelet LysateBone marrowMesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Effectiveness of using PLGA scaffolds seeded with autologous bone marrow MSCs by Radiograph

    6 months

Study Arms (1)

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

MSC-PLGABIOLOGICAL

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

MSC-PLGA

Eligibility Criteria

Age4 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with diagnosis of cancer
  • Patients enrolled in other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Therapy Center

Amman, 11942, Jordan

RECRUITING

MeSH Terms

Conditions

Bone Cysts, Aneurysmal

Condition Hierarchy (Ancestors)

Bone CystsCystsNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Abdalla Awidi

    University of Jordan

    STUDY DIRECTOR

Central Study Contacts

Shayma Nazzal, Msc

CONTACT

00962795770585shayma20585@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher, Msc

Study Record Dates

First Submitted

February 23, 2017

First Posted

February 28, 2017

Study Start

May 3, 2018

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

JO(1)