OsteoporosisPhase 2NCT04501354
Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients
A Phase 2 study testing Mesenchymal Stem Cell in people with Osteoporosis, run by Ahmad Jabir Rahyussalim at 1 site in Indonesia.
Trial summary
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord in improving the quality and quantity of spinal density of osteoporosis patients proven by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate improvement of quality of pain with visual… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Mesenchymal Stem Cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2020to 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients older than 50 yrs old.
- Female patients older than 40 years old.
- Patients enrolled in Cipto Mangunkusumo Hospital with osteoporosis confirmed by BMD test.
- Patients with no history of autoimun disease (SLE, Addison's disease, Chron's disease) and other diseases related to osteoporosis.
- Patients with no history of consuming drug related osteoporosis.
- No active infection confirmed by HbsAg, HIV, CMV, Rubella and Toxoplasma examination.
- Agree to participate the study by signing informed consent form.
Who cannot join
- Patients with autoimun diesasde (SLE, Addison's diesase, Chron's disease and other osteoporosis related disease.
- Patients under immunosuppressive, anticoagulant or corticosteroid treatment.
- Paralysis patients after surgical treatment
- Patients under 20 years old
- Declined to participate 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: Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients (Clinical Trial)
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord in improving the quality and quantity of spinal density of osteoporosis patients proven by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate improvement of quality of pain with visual analog scale (VAS).
Read the detailed description
Currently, preventive and therapeutic strategies for osteoporosis patients are based on calcium and vitamin D supplementation, the use of pharmacological agents that inhibit bone resorption such as bisphosphonates, and sometimes calcitonin. Although bisphosphonates have been found to reduce osteoporosis, clinical use for these drugs has been limited because of its potential to produce serious side effects, such as mandibular osteonecrosis and atypical femoral fractures. Therefore, new therapeutic strategies for osteoporosis are needed.
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord. Patients who have received mesenchymal stem cell therapy (MSC) are expected to have positive effects such as reduced pain sensation in the back assessed by Visual Analog Scale (VAS), improvement in the range of motion (ROM), improving the quality of osteoporosis patients's bone proven by the results of Bone Mass Density (BMD) and improvement in patients' quality of life.
- Conditions
- Osteoporosis
- Being tested
- Mesenchymal Stem Cell
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellDrug
Mesenchymal Stem Cell + NaCl 0,9% 2ml
| Study group | Role | What they receive |
|---|---|---|
| UC-Mesenchymal Stem Cell | Experimental | Allogeneic Mesenchymal Stem Cell from umbilical cord Receives: Drug: Mesenchymal Stem Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mass Density (BMD)
Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD).
- Above Standard Deviation (SD) (-1) means normal
- Between SD (-1) and (-2.5) is classified as osteopenia. Osteopenia is a condition when bone density is lower than the average, but not as low as osteoporosis.
- Below SD (-2.5) is categorized as osteoporosis.
The numbers are expected to be higher after MSC implantation.
Measured: 6 months
Visual Analog Scale (VAS)
Evaluates pain quality using Visual Analog Scale (VAS) from 0 - 10. Zero is no pain at all, one is the the least pain and ten is the most painful. The numbers are expected to be lower after MSC implantation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- 5 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
- NCT04501354
- Sponsor's protocol ID
- 19-08-1018
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients (Clinical Trial)
- ClinicalTrials.gov ID
- NCT04501354
- Acronym / sponsor ID
- 19-08-1018
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Ahmad Jabir RahyussalimUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Aug 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 will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord in improving the quality and quantity of spinal density of osteoporosis patients proven by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate improvement of quality of pain with visual analog scale (VAS).
Detailed description
Currently, preventive and therapeutic strategies for osteoporosis patients are based on calcium and vitamin D supplementation, the use of pharmacological agents that inhibit bone resorption such as bisphosphonates, and sometimes calcitonin. Although bisphosphonates have been found to reduce osteoporosis, clinical use for these drugs has been limited because of its potential to produce serious side effects, such as mandibular osteonecrosis and atypical femoral fractures. Therefore, new therapeutic strategies for osteoporosis are needed.
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord. Patients who have received mesenchymal stem cell therapy (MSC) are expected to have positive effects such as reduced pain sensation in the back assessed by Visual Analog Scale (VAS), improvement in the range of motion (ROM), improving the quality of osteoporosis patients's bone proven by the results of Bone Mass Density (BMD) and improvement in patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC-Mesenchymal Stem Cell | Experimental | Drug: Mesenchymal Stem CellAllogeneic Mesenchymal Stem Cell from umbilical cord |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients older than 50 yrs old.
- Female patients older than 40 years old.
- Patients enrolled in Cipto Mangunkusumo Hospital with osteoporosis confirmed by BMD test.
- Patients with no history of autoimun disease (SLE, Addison's disease, Chron's disease) and other diseases related to osteoporosis.
- Patients with no history of consuming drug related osteoporosis.
Key exclusion criteria (5 listed)
- Patients with autoimun diesasde (SLE, Addison's diesase, Chron's disease and other osteoporosis related disease.
- Patients under immunosuppressive, anticoagulant or corticosteroid treatment.
- Paralysis patients after surgical treatment
- Patients under 20 years old
- Declined to participate 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 CellMesenchymal Stem Cell + NaCl 0,9% 2ml | Drug | UC-Mesenchymal Stem Cell |
Primary outcome
Bone Mass Density (BMD)
Time frame: 6 months
Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD). 1. Above Standard Deviation (SD) (-1) means normal 2. Between SD (-1) and (-2.5) is classified as osteopenia. Osteopenia is a condition when bone density is lower than the average, but not as low as osteoporosis. 3. Below SD (-2.5) is categorized as osteoporosis. The numbers are expected to be higher after MSC implantation.
Visual Analog Scale (VAS)
Time frame: 6 months
Evaluates pain quality using Visual Analog Scale (VAS) from 0 - 10. Zero is no pain at all, one is the the least pain and ten is the most painful. The numbers are expected to be lower after MSC implantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
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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 in people with Osteoporosis, 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 7 inclusion and 5 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 7 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 (+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?
Bone Mass Density (BMD) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 7 Aug 2020.