Spinal TuberculosisPhase 2NCT04493918
Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection
A Phase 2 study testing Mesenchymal Stem cell + Nacl 0.9% and NaCl 0.9% in people with Spinal Tuberculosis and Mesenchymal Stem Cell, run by Ahmad Jabir Rahyussalim at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 15 to 64 years
- Conditions the study is for
- Spinal Tuberculosis, Mesenchymal Stem Cell
- What is being tested?
- Mesenchymal Stem cell + Nacl 0.9% and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 May 2017to 30 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinicoradiologically diagnoses Spinal Tuberculosis
- receives Anti TB drugs
- minimun destruction 1/3 vertebral body
Who cannot join
- patient under 15 years old
- reject to be included in the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
Ahmad Jabir Rahyussalim, MD,PhD,SpOT, +62811819466, rahyussalim71@ui.ac.id
Trie K Kurniawati, SSi, +628121134311, trie3k@ui.ac.id
About this study
Official title: Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)
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
Read the detailed 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.
- Conditions
- Spinal Tuberculosis, Mesenchymal Stem Cell
- Being tested
- Mesenchymal Stem cell + Nacl 0.9%, NaCl 0.9%
- Keywords
- Mycobacterium tuberculosis
- Medical subject headings
- Tuberculosis, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
NaCl 0.9%Combination product
Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml
| Study group | Role | What they receive |
|---|---|---|
| MSC Group | Experimental | Mesenchymal Stem Cell + NaCl 0,9% 2ml Receives: Combination Product: Mesenchymal Stem cell + Nacl 0.9%; Combination Product: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertebral bony fusion
trabecular bone on xray and CT scan
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start21 May 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmad Jabir Rahyussalim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Jabir Rahyussalim, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493918
- Sponsor's protocol ID
- 18-04-0389
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Local Implantation of the Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection (Clinical Trial)
- ClinicalTrials.gov ID
- NCT04493918
- Acronym / sponsor ID
- 18-04-0389
- Conditions
- Spinal Tuberculosis, Mesenchymal Stem Cell
- Keywords
- Mycobacterium tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ahmad Jabir RahyussalimUniversity, hospital or other
- Study start
- 21 May 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC Group | Experimental | Combination Product: Mesenchymal Stem cell + Nacl 0.9%, Combination Product: NaCl 0.9%Mesenchymal Stem Cell + NaCl 0,9% 2ml |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinicoradiologically diagnoses Spinal Tuberculosis
- receives Anti TB drugs
- minimun destruction 1/3 vertebral body
Key exclusion criteria (2 listed)
- patient under 15 years old
- reject to be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Combination product | MSC Group |
| NaCl 0.9%Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml | Combination product | MSC Group |
Primary outcome
Vertebral bony fusion
Time frame: 1 Year
trabecular bone on xray and CT scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Tuberculosis
Not yet recruitingPhase 2
Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
Mild Spinal Tuberculosis
RecruitingObservational study
Gene Expression Profiles in Spinal Tuberculosis.
Tuberculosis, Spinal, Tuberculosis, Osteoarticular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal Stem cell + Nacl 0.9% and NaCl 0.9% in people with Spinal Tuberculosis and Mesenchymal Stem Cell, run by Ahmad Jabir Rahyussalim at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad Jabir Rahyussalim, PhD (+62811819466, rahyussalim71@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertebral bony fusion (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.