Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection
NCT ID: NCT04493918
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2017-05-21
2020-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MSC Group
Mesenchymal Stem Cell + NaCl 0,9% 2ml
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
NaCl 0.9%
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml
Interventions
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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
NaCl 0.9%
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml
Eligibility Criteria
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Inclusion Criteria
* receives Anti TB drugs
* minimun destruction 1/3 vertebral body
Exclusion Criteria
* reject to be included in the study
15 Years
64 Years
ALL
No
Sponsors
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Ahmad Jabir Rahyussalim
OTHER
Responsible Party
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Ahmad Jabir Rahyussalim
Dr. dr. Rahyussalim SpOT(K)
Locations
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Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18-04-0389
Identifier Type: -
Identifier Source: org_study_id
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