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

Mesenchymal Stem Cell Clinical Trial

Official title:

Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04493918
• Other study ID #: 18-04-0389
• Status: Recruiting
• Phase: Phase 2
• Start date: May 21, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: Indonesia University
• Contact: Ahmad Jabir Rahyussalim, PhD
• Phone: +62811819466
• Email: rahyussalim71[@]ui.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Mesenchymal Stem Cell
• Spinal Tuberculosis
• Tuberculosis
• Tuberculosis, Spinal

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Ahmad Jabir Rahyussalim

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertebral bony fusion	trabecular bone on xray and CT scan	1 Year