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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC Group | Experimental | Mesenchymal Stem Cell + NaCl 0,9% 2ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem cell + Nacl 0.9% | Combination Product | Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit |
| Measure | Description | Time Frame |
|---|---|---|
| Vertebral bony fusion | trabecular bone on xray and CT scan | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Jabir Rahyussalim, PhD | Contact | +62811819466 | rahyussalim71@ui.ac.id | |
| Tri Kurniawati, Mrs | Contact | +628121134311 | trie3k@ui.ac.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Recruiting | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D014399 | Tuberculosis, Spinal |
| ID | Term |
|---|---|
| D014394 | Tuberculosis, Osteoarticular |
| D000092225 | Tuberculosis, Extrapulmonary |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Participants do not know which treatment they receives. Outcome assessor is a radiologist
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| NaCl 0.9% | Combination Product | Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml |
|
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001850 | Bone Diseases, Infectious |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D017670 |
| Sodium Compounds |