Multiple System AtrophyNCT04876326
Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy
A study testing Autologous Adipose Mesenchymal Stem Cell Implantation, Allogeneic Umbilical Cord Mesenchymal Stem Cell Implantation and Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome Implantation in people with Multiple System Atrophy and Parkinsonism, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The prevalence of Multiple System Atrophy (MSA) is reported to be between 3.4 - 4.9 cases per 100,000 population. The estimated average incidence is 0.6 - 0.7 cases per 100,000 people per year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple System Atrophy, Parkinsonism, Multiple System Atrophy, Parkinson Variant
- What is being tested?
- Autologous Adipose Mesenchymal Stem Cell Implantation, Allogeneic Umbilical Cord Mesenchymal Stem Cell Implantation and Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome Implantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Oct 2020to 5 Oct 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients developed MSA based on clinical examination and consensus MSA criteria.
- Patients diagnosed with MSA for less than 4 years.
- Patients with an anticipated survival of at least 3 years in the opinion of the examiner.
- Patients with MOCa and Mini Mental State Examination (MMSE) values of more than 24.
- For Adipose Autologous-MSC group subjects were not experiencing active infection, which was confirmed by screening for HbSAg, Anti HCV, Syphilis, HIV, CMV, Rubella, and Toxoplasma.
- Subjects are willing to participate in research and fill out an informed consent form.
- Do not have autoimmune disorder, or undergoes management disorders and / or other diseases related to MSA
- Subjects are willing to participate in research and fill out an informed consent form.
Who cannot join
- Suffer from systemic autoimmune diseases (systemetic lupus erythomatosus, Addison's disease, Crohn's disease, arthritis management), immunodeficiency (SIDA), or blood clotting disorders or management of malignant diseases (diseases associated with MSA)
- Undergo immunosuppressive therapy, anticoagulants or corticosteroids.
- Patients with malignant neoplasms and close family history of neoplasms.
- already had history of spinal surgery, have paralysis or have spinal diseases.
- Patients with a history of electroconvulsive therapy.
- Patients with a history of brain surgery for Parkinson's disease.
Show all 9Show fewer
- Patients with systemic or local infections located close to the injection site.
- Undergo immunosuppressive therapy, anticoagulants or corticosteroids.
- The patient was not willing to take part in the study and did not fill out informed consent.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta
Ismail H Dilogo, MD, PhD, +62211500135, ismailortho@gmail.com
Ismail H Dilogo, MD, PhD
About this study
The prevalence of Multiple System Atrophy (MSA) is reported to be between 3.4 - 4.9 cases per 100,000 population. The estimated average incidence is 0.6 - 0.7 cases per 100,000 people per year. Many patients are not diagnosed properly during their lifetime because of the difficulty in differentiating MSA from other disorders. Approximately 29 - 33% of patients with isolated late onset cerebellar ataxia and 8 - 10% of patients with parkinsonism will develop MSA.
There are currently no therapies that can cure or stop the progression of the disease. The current pharmacological therapy is only to relieve symptoms. Mesenchymal stem cells (MSC) are considered an efficient source of cells for therapy, because they can be safely harvested and transplanted to donors or patients, have low immunogenicity, and have broad therapeutic potential. Results from preliminary preclinical and clinical trials indicate the potential of MSC-based treatment in meeting several key aspects of neurodegeneration. Stem cell-based therapy for neurodegenerative diseases aims to stop clinical damage by regenerating and by providing local support for damaged tissue, in addition after transplantation, MSCs have been shown to be capable of penetrating the lesion area and thus have great potential use as a means of administering therapeutic agents.
Read more
The subjects of this study were patients who experienced possible MSA based on the consensus clinical criteria for MSA. There will be three treatment groups with a total sample of 5 subjects each.
Group 1 will receives MSC-Adipose Autologous with doses 2x50 million cells intratechally.
Group 2 will receives MSC-Umbilical Cord Allogeneic with doses 2x 50 million cells intratechally.
Group 3 will receives MSC-Umbilical Cord Allogeneic with doses 2x50 million cells intratechally and 2x10cc secretome MSC from Adipose Intravenously.
Clinical improvement will be evaluated using the UMSARS scale, PET-Scans, MRI, DaTScan, IGF-1, BDNF, Sympathetic skin respons (SSR), EMG, Composite Autonomic Severity Score (CASS), High definition-Optical coherence tomography (HD-OCT), ERG, VEP, Log MAR chart, Ishihara test and side adverse effect on MSC.
This study is divided into six timeframes : Before an implantation, First Month after second implantation, Third month after secondary implantation, Sixth month after second implantation, Ninth month after second implantation and Twelve month after second implantation. The differences between the test variables are then used as an indicator to assess clinical improvement within the subjects.
- Being tested
- Autologous Adipose Mesenchymal Stem Cell Implantation, Allogeneic Umbilical Cord Mesenchymal Stem Cell Implantation, Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome Implantation
- Keywords
- Multiple System Atrophy, Parkinson Variant, Mesenchymal Stem Cell, Parkinsonism, UMSARS, MRI, FGD-PET SCAN, DaTScan, SSR, RR-Interval, Composite Autonomic Severity Score, ILG-1, BDNF, ERG (Electroretinogram), VEP (Visual Evoked Potential), HD-OCT (High Definition-optical coherence tomography)
- Medical subject headings
- Multiple System Atrophy, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Mesenchymal Stem Cell ImplantationBiological
Before taking adipose tissue, each subject was screened including HbSAg, Anti HbS, Anti HCV, HIC, MCV and syphilis tests.
Adipose tissue was taken through 5 grams of subcutaneous fat biopsy from the abdomen of each subject and put into a transport medium and then sent to the RSCM-FKUI cGMP IPT Stem Cells Laboratory for immediate isolation of mesenchymal stem cells.
MSC that has been isolated will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.
The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture.
The MSC to be injected into the subject will be prepared in 2cc physiological NaCl transport medium just before implantation.
The adipose secretion used is prepared in whole form as much as 10cc in a 10cc syringe.
Allogeneic Umbilical Cord Mesenchymal Stem Cell ImplantationBiological
Before taking the umbilical cord tissue, a pregnant woman's donor was screened including HbSAg, Anti HbS, Anti HCV, HIC, MCV and syphilis tests.
Immediately after delivery, the umbilical cord was collected and stored in a sterile specimen plate containing 0.9% NaCl at 4⁰C.
The umbilical cord is transported to the GMP standard culture laboratory at the UPT TK Stem Cells RSCM-FKUI for isolation process of mesenchymal stem cells. Sample processing was carried out within 8 hours of delivery to maintain cell viability.
MSC that has been isolated will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.
The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture.
The MSC to be injected into the subject will be prepared in a suitable transport medium just prior to implantation.
Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome ImplantationBiological
Before taking adipose and umbilical cord tissue, each subject was screened. -For Adipose tissue : The adipose secretion used is prepared in whole form as much as 10cc in a 10cc syringe.
-Uc-MSC : Immediately after delivery, the umbilical cord was collected and stored in a sterile specimen plate containing 0.9% NaCl at 4⁰C.
The umbilical cord is transported to the GMP standard culture laboratory to have isolation process of mesenchymal stem cells. Sample processing was carried out within 8 hours of delivery to maintain cell viability.
Later it will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose MSC Group | Active comparator | This group will receive the implantation of autologous mesenchymal stem cell origin of adipose tissue with a dose of 2 x 50 million cells given with a distance of 1 month Receives: Biological: Autologous Adipose Mesenchymal Stem Cell Implantation |
| Allogeneic Umbilical Cord MSC Group | Active comparator | This group will receive intrathecal implantation of allogeneic mesenchymal stem cells from the umbilical cord with a dose of 2 x 50 million cells given a distance of 1 month. Receives: Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell Implantation |
| Allogeneic Umbilical Cord MSC and Adipose Secretome Group | Active comparator | This group will receive intrathecal implantation of allogeneic mesenchymal stem cells from the umbilical cord as much as 2 x 50 million followed by 2 x 10cc mesenchymal stem cell secretions from adipose tissue intravenously given at a distance of 1 month. Receives: Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Clinical Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
Subjects will be evaluated by Neurological test
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Changes of Clinical Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
Subjects will be evaluated by UMSARS(Unified Multiple System Atrophy Rating Scale)
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Changes of structures improvement of the eyes from Baseline to 1,3,6,9 and 12 months after second implantation
an increase in the thickness of the Retinal Nerve Fiber Layer(RNFL) checked from the High Definition-Optical Coherence Tomography examination(HD-OCT)
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Changes of structures improvement of the eyes from Baseline to 1,3,6,9 and 12 months after second implantation
an increase in the Ganglion Cell Complex (GCC) checked from the High Definition-Optical Coherence Tomography examination(HD-OCT)
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Changes of the eyesight from Baseline to 1,3,6,9 and 12 months after second implantation
improvement of eyesight will be checked using LogMar Test
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Changes of the eyesight from Baseline to 1,3,6,9 and 12 months after second implantation
improvement of eyesight will be checked using Ishihara test
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Changes of the eyesight from Baseline to 1,3,6,9 and 12 months after second implantation
improvement of eyesight will be checked using VEP (Visual Evoked Potential)
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Changes of the eyesight from Baseline to 1,3,6,9 and 12 months after second implantation
improvement of eyesight will be checked using ERG (Electroretinogram)
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Imaging Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
The Brain will be checked to see Changes of MRI to see increased FDG Uptake
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Imaging Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
The Brain will be checked to see Changes of FGD-PET SCAN to see increased FDG Uptake
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Imaging Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
The Brain will be checked to see Changes of DaTScan to see increased FDG Uptake
Measured: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start5 Oct 2020
- Primary completion5 Oct 2021 (estimated)
- Study completion5 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Hadisoebroto Dilogo, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876326
- Sponsor's protocol ID
- TGHISMMSCMSA
- Status last verified
- May 2021
- First submitted
- 25 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Use of Autologous and Allogeneic Mesenchymal Stem Cells in Patients With Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT04876326
- Acronym / sponsor ID
- TGHISMMSCMSA
- Keywords
- Multiple System Atrophy, Parkinson Variant, Mesenchymal Stem Cell, Parkinsonism, UMSARS, MRI, FGD-PET SCAN, DaTScan, SSR, RR-Interval
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 5 Oct 2021 (estimated)
- Study completion
- 5 Oct 2021 (estimated)
- First posted
- 6 May 2021 (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.
The prevalence of Multiple System Atrophy (MSA) is reported to be between 3.4 - 4.9 cases per 100,000 population. The estimated average incidence is 0.6 - 0.7 cases per 100,000 people per year. Many patients are not diagnosed properly during their lifetime because of the difficulty in differentiating MSA from other disorders. Approximately 29 - 33% of patients with isolated late onset cerebellar ataxia and 8 - 10% of patients with parkinsonism will develop MSA.
There are currently no therapies that can cure or stop the progression of the disease. The current pharmacological therapy is only to relieve symptoms. Mesenchymal stem cells (MSC) are considered an efficient source of cells for therapy, because they can be safely harvested and transplanted to donors or patients, have low immunogenicity, and have broad therapeutic potential. Results from preliminary preclinical and clinical trials indicate the potential of MSC-based treatment in meeting several key aspects of neurodegeneration. Stem cell-based therapy for neurodegenerative diseases aims to stop clinical damage by regenerating and by providing local support for damaged tissue, in addition after transplantation, MSCs have been shown to be capable of penetrating the lesion area and thus have great potential use as a means of administering therapeutic agents.
The subjects of this study were patients who experienced possible MSA based on the consensus clinical criteria for MSA. There will be three treatment groups with a total sample of 5 subjects each.
Group 1 will receives MSC-Adipose Autologous with doses 2x50 million cells intratechally.
Group 2 will receives MSC-Umbilical Cord Allogeneic with doses 2x 50 million cells intratechally.
Group 3 will receives MSC-Umbilical Cord Allogeneic with doses 2x50 million cells intratechally and 2x10cc secretome MSC from Adipose Intravenously.
Clinical improvement will be evaluated using the UMSARS scale, PET-Scans, MRI, DaTScan, IGF-1, BDNF, Sympathetic skin respons (SSR), EMG, Composite Autonomic Severity Score (CASS), High definition-Optical coherence tomography (HD-OCT), ERG, VEP, Log MAR chart, Ishihara test and side adverse effect on MSC.
This study is divided into six timeframes : Before an implantation, First Month after second implantation, Third month after secondary implantation, Sixth month after second implantation, Ninth month after second implantation and Twelve month after second implantation. The differences between the test variables are then used as an indicator to assess clinical improvement within the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose MSC Group | Active comparator | Biological: Autologous Adipose Mesenchymal Stem Cell ImplantationThis group will receive the implantation of autologous mesenchymal stem cell origin of adipose tissue with a dose of 2 x 50 million cells given with a distance of 1 month |
| Allogeneic Umbilical Cord MSC Group | Active comparator | Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell ImplantationThis group will receive intrathecal implantation of allogeneic mesenchymal stem cells from the umbilical cord with a dose of 2 x 50 million cells given a distance of 1 month. |
| Allogeneic Umbilical Cord MSC and Adipose Secretome Group | Active comparator | Biological: Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome ImplantationThis group will receive intrathecal implantation of allogeneic mesenchymal stem cells from the umbilical cord as much as 2 x 50 million followed by 2 x 10cc mesenchymal stem cell secretions from adipose tissue intravenously given at a distance of 1 month. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients developed MSA based on clinical examination and consensus MSA criteria.
- Patients diagnosed with MSA for less than 4 years.
- Patients with an anticipated survival of at least 3 years in the opinion of the examiner.
- Patients with MOCa and Mini Mental State Examination (MMSE) values of more than 24.
- For Adipose Autologous-MSC group subjects were not experiencing active infection, which was confirmed by screening for HbSAg, Anti HCV, Syphilis, HIV, CMV, Rubella, and Toxoplasma.
Key exclusion criteria (9 listed)
- Suffer from systemic autoimmune diseases (systemetic lupus erythomatosus, Addison's disease, Crohn's disease, arthritis management), immunodeficiency (SIDA), or blood clotting disorders or management of malignant diseases (diseases associated with MSA)
- Undergo immunosuppressive therapy, anticoagulants or corticosteroids.
- Patients with malignant neoplasms and close family history of neoplasms.
- already had history of spinal surgery, have paralysis or have spinal diseases.
- Patients with a history of electroconvulsive therapy.
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 |
|---|---|---|
| Autologous Adipose Mesenchymal Stem Cell ImplantationBefore taking adipose tissue, each subject was screened including HbSAg, Anti HbS, Anti HCV, HIC, MCV and syphilis tests. Adipose tissue was taken through 5 grams of subcutaneous fat biopsy from the abdomen of each subject and put into a transport medium and then sent to the RSCM-FKUI cGMP IPT Stem Cells Laboratory for immediate isolation of mesenchymal stem cells. MSC that has been isolated will be cultured using the appropriate medium until it reaches the desired passage and the number of cells. The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture. The MSC to be injected into the subject will be prepared in 2cc physiological NaCl transport medium just before implantation. The adipose secretion used is prepared in whole form as much as 10cc in a 10cc syringe. | Biological | Autologous Adipose MSC Group |
| Allogeneic Umbilical Cord Mesenchymal Stem Cell ImplantationBefore taking the umbilical cord tissue, a pregnant woman's donor was screened including HbSAg, Anti HbS, Anti HCV, HIC, MCV and syphilis tests. Immediately after delivery, the umbilical cord was collected and stored in a sterile specimen plate containing 0.9% NaCl at 4⁰C. The umbilical cord is transported to the GMP standard culture laboratory at the UPT TK Stem Cells RSCM-FKUI for isolation process of mesenchymal stem cells. Sample processing was carried out within 8 hours of delivery to maintain cell viability. MSC that has been isolated will be cultured using the appropriate medium until it reaches the desired passage and the number of cells. The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture. The MSC to be injected into the subject will be prepared in a suitable transport medium just prior to implantation. | Biological | Allogeneic Umbilical Cord MSC Group |
| Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome ImplantationBefore taking adipose and umbilical cord tissue, each subject was screened. -For Adipose tissue : The adipose secretion used is prepared in whole form as much as 10cc in a 10cc syringe. -Uc-MSC : Immediately after delivery, the umbilical cord was collected and stored in a sterile specimen plate containing 0.9% NaCl at 4⁰C. The umbilical cord is transported to the GMP standard culture laboratory to have isolation process of mesenchymal stem cells. Sample processing was carried out within 8 hours of delivery to maintain cell viability. Later it will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture. | Biological | Allogeneic Umbilical Cord MSC and Adipose Secretome Group |
Primary outcome
Changes of Clinical Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Subjects will be evaluated by Neurological test
Changes of Clinical Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
Subjects will be evaluated by UMSARS(Unified Multiple System Atrophy Rating Scale)
Changes of structures improvement of the eyes from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
an increase in the thickness of the Retinal Nerve Fiber Layer(RNFL) checked from the High Definition-Optical Coherence Tomography examination(HD-OCT)
Changes of structures improvement of the eyes from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
an increase in the Ganglion Cell Complex (GCC) checked from the High Definition-Optical Coherence Tomography examination(HD-OCT)
Changes of the eyesight from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
improvement of eyesight will be checked using LogMar Test
Changes of the eyesight from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
improvement of eyesight will be checked using Ishihara test
Changes of the eyesight from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
improvement of eyesight will be checked using VEP (Visual Evoked Potential)
Changes of the eyesight from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
improvement of eyesight will be checked using ERG (Electroretinogram)
Imaging Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
The Brain will be checked to see Changes of MRI to see increased FDG Uptake
Imaging Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
The Brain will be checked to see Changes of FGD-PET SCAN to see increased FDG Uptake
Imaging Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation
Time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation
The Brain will be checked to see Changes of DaTScan to see increased FDG Uptake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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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 study testing Autologous Adipose Mesenchymal Stem Cell Implantation, Allogeneic Umbilical Cord Mesenchymal Stem Cell Implantation and Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome Implantation in people with Multiple System Atrophy and Parkinsonism, run by Universitas Indonesia 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 8 inclusion and 9 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 6 May 2021. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Clinical Evaluation from Baseline to 1,3,6,9 and 12 months after second implantation (time frame: Pre-implantation, 1st Month, 3rd Months, 6th Months , 9th, 12th Months After Second Implantation). The study lists 11 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 6 May 2021.