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

Ahmad Jabir Rahyussalim

Status and phase: Unknown; Phase 2

Conditions: Spinal Tuberculosis; Mesenchymal Stem Cell

Treatments: Combination Product: Mesenchymal Stem cell + Nacl 0.9%; Combination Product: NaCl 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT04493918

18-04-0389

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 15 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

MSC Group

Experimental group

Description:

Mesenchymal Stem Cell + NaCl 0,9% 2ml

Treatment:

Combination Product: Mesenchymal Stem cell + Nacl 0.9%

Combination Product: NaCl 0.9%