Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection
Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2017
CompletedFirst Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedAugust 3, 2020
July 1, 2020
3.6 years
July 28, 2020
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vertebral bony fusion
trabecular bone on xray and CT scan
1 Year
Study Arms (1)
MSC Group
EXPERIMENTALMesenchymal Stem Cell + NaCl 0,9% 2ml
Interventions
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml
Eligibility Criteria
You may qualify if:
- Clinicoradiologically diagnoses Spinal Tuberculosis
- receives Anti TB drugs
- minimun destruction 1/3 vertebral body
You may not qualify if:
- patient under 15 years old
- reject to be included in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Participants do not know which treatment they receives. Outcome assessor is a radiologist
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr. dr. Rahyussalim SpOT(K)
Study Record Dates
First Submitted
July 28, 2020
First Posted
July 30, 2020
Study Start
May 21, 2017
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
August 3, 2020
Record last verified: 2020-07