Back to resultsEffectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection
Primary Purpose
Spinal Tuberculosis, Mesenchymal Stem Cell
Status
Unknown status
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Mesenchymal Stem cell + Nacl 0.9%
NaCl 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Tuberculosis focused on measuring Mycobacterium tuberculosis
Eligibility Criteria
Inclusion Criteria:
- Clinicoradiologically diagnoses Spinal Tuberculosis
- receives Anti TB drugs
- minimun destruction 1/3 vertebral body
Exclusion Criteria:
- patient under 15 years old
- reject to be included in the study
Sites / Locations
- Cipto Mangunkusumo HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MSC Group
Arm Description
Mesenchymal Stem Cell + NaCl 0,9% 2ml
Outcomes
Primary Outcome Measures
Vertebral bony fusion
trabecular bone on xray and CT scan
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04493918
Brief Title
Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection
Official Title
Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmad Jabir Rahyussalim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc
Detailed Description
Mesenchymal Stem Cell are implanted in Spinal Tuberculosis patient. MSC has inflammatory effect and the ability to form into new bone.
In Spinal Tuberculosis, the spread of bacteria is commonly hematogenous, where the focus of infection is at the anterior part of the vertebrae near the subchondral bone. The infection process continues, where the necrotic casseous fragments formed into local abcess that may spread to the sorrounding area.
Patient with spinal tuberculosis who receives Anti TB Drug, is planned to undergo debridement, spinal stabilization. After thorough debridement, patient who fall into control group receives normal saline injection, patients who fall into treatment group will receive Mesenchymal Stem Cell.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Tuberculosis, Mesenchymal Stem Cell
Keywords
Mycobacterium tuberculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participants do not know which treatment they receives. Outcome assessor is a radiologist
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MSC Group
Arm Type
Experimental
Arm Description
Mesenchymal Stem Cell + NaCl 0,9% 2ml
Intervention Type
Combination Product
Intervention Name(s)
Mesenchymal Stem cell + Nacl 0.9%
Intervention Description
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit
Intervention Type
Combination Product
Intervention Name(s)
NaCl 0.9%
Intervention Description
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml
Primary Outcome Measure Information:
Title
Vertebral bony fusion
Description
trabecular bone on xray and CT scan
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinicoradiologically diagnoses Spinal Tuberculosis
receives Anti TB drugs
minimun destruction 1/3 vertebral body
Exclusion Criteria:
patient under 15 years old
reject to be included in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Jabir Rahyussalim, PhD
Phone
+62811819466
Email
rahyussalim71@ui.ac.id
First Name & Middle Initial & Last Name or Official Title & Degree
Tri Kurniawati, Mrs
Phone
+628121134311
Email
trie3k@ui.ac.id
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Jabir Rahyussalim, MD,PhD,SpOT
Phone
+62811819466
Email
rahyussalim71@ui.ac.id
First Name & Middle Initial & Last Name & Degree
Trie K Kurniawati, SSi
Phone
+628121134311
Email
trie3k@ui.ac.id
First Name & Middle Initial & Last Name & Degree
Ahmad Jabir Rahyussalim, MD,PhD,SpOT
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection
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