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Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection

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ClinicalTrials.gov Identifier: NCT04493918
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmad Jabir Rahyussalim, Indonesia University

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

Condition or disease Intervention/treatment Phase
Spinal Tuberculosis Mesenchymal Stem Cell Combination Product: Mesenchymal Stem cell + Nacl 0.9% Combination Product: NaCl 0.9% Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Participants do not know which treatment they receives. Outcome assessor is a radiologist
Primary Purpose: Treatment
Official Title: Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)
Actual Study Start Date : May 21, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: MSC Group
Mesenchymal Stem Cell + NaCl 0,9% 2ml
Combination Product: Mesenchymal Stem cell + Nacl 0.9%
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit

Combination Product: NaCl 0.9%
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml




Primary Outcome Measures :
  1. Vertebral bony fusion [ Time Frame: 1 Year ]
    trabecular bone on xray and CT scan



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493918


Contacts
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Contact: Ahmad Jabir Rahyussalim, PhD +62811819466 rahyussalim71@ui.ac.id
Contact: Tri Kurniawati, Mrs +628121134311 trie3k@ui.ac.id

Locations
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Indonesia
Cipto Mangunkusumo Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Ahmad Jabir Rahyussalim, MD,PhD,SpOT    +62811819466    rahyussalim71@ui.ac.id   
Contact: Trie K Kurniawati, SSi    +628121134311    trie3k@ui.ac.id   
Principal Investigator: Ahmad Jabir Rahyussalim, MD,PhD,SpOT         
Sponsors and Collaborators
Ahmad Jabir Rahyussalim
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Responsible Party: Ahmad Jabir Rahyussalim, Dr. dr. Rahyussalim SpOT(K), Indonesia University
ClinicalTrials.gov Identifier: NCT04493918    
Other Study ID Numbers: 18-04-0389
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Ahmad Jabir Rahyussalim, Indonesia University:
Mycobacterium tuberculosis
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Tuberculosis, Spinal
Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Latent Infection
Tuberculosis, Osteoarticular
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spondylitis
Spinal Diseases