DementiaPhase 1NCT06632470
Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)
A Phase 1 study testing Secretome injection and Vitamin B12 Injection in people with Dementia and Moderate Dementia, run by Baermed at 1 site in Indonesia.
Trial summary
The goal of this clinical trial if to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with moderate dementia. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Moderate Dementia
- What is being tested?
- Secretome injection and Vitamin B12 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Oct 2024to 1 Oct 2025
- Phase
- Phase 1
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age \> 60 years old
- Patient diagnosed with dementia confirmed by psychiatrist or neurologist based on DSM-4 or ICD 10
- Patient with Mini-Mental State Examination (MMSE) between 10 to 20 indicating moderate cognitive impairment
- Patient is in stable condition without life threatening disease or uncontrolled medical condition
- Patient undergoing stable dose treatment for other medical condition at least 4 months before the trial
- Patient with care giver or supporting family who can assist patient with research protocol
Who cannot join
- Patient has dementia due to other medical condition such as severe head trauma, brain infection or history of drug abuse
- Patient with uncontrolled medical condition such as severe cardiovascular disease, chronic lung disease, cancer, or systemic infection
- Patient with severe psychiatry disorder such as schizophrenia and bipolar disorder
- Patient is receiving experimental drugs or participates in experimental studies for the last 30 days before the trial
- Patient who has allergy or hypersensitivity reaction towards secretome
- Patient with medical complications or surgery complications that require immediate interventions or other life threatening complications
- Patient is unable to provide written informed consent and not capable to understand and comply to research protocol
- Patient is unwilling and not capable to follow research protocol including follow up evaluations and blood sampling according to schedule
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Panti Werda Hana
Tangeran Selatan, Banten, 15431
Dr. dr. Noer Saelan Tadjudin Sp.KJ, +628119211219, saelan_untar@yahoo.co.id
About this study
The goal of this clinical trial if to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with moderate dementia. The main questions it aims to answer are:
- Is HUCMSC derived secretome safe to be use as a therapy in patients with moderate dementia?
- How does HUCMSC derived secretome affect pro inflammatory and anti inflammatory cytokine (IL-6 and TNF alfa) in patient with moderate dementia?
- What is the relationship between HUCMSC derived secretome therapy with mini mental state examination? Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored)
Read more
Participants will
- Be injected with HUCMSC derived secretome or Vitamin B12 every two weeks for 4 months
- Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment) and participants will do several blood test and mental examination
- Conditions
- Dementia, Moderate Dementia
- Being tested
- Secretome injection, Vitamin B12 Injection
- Keywords
- dementia, moderate dementia, neurocognitive impairment, secretome, HUCSMC, stem cells
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secretome injectionDrug
Also called secretome, hucmsc
Patient will receive 3 ml of secretome intramuscular injection every two weeks for four months
Vitamin B12 InjectionDrug
Patient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months
| Study group | Role | What they receive |
|---|---|---|
| Secretome injection | Experimental | patient will receive secretome injection every two weeks for four months Receives: Drug: Secretome injection |
| Vitamin B12 | Placebo comparator | patient will receive 1 ampule of vitamin b12 every two weeks for 4 months Receives: Drug: Vitamin B12 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of moderate dementia patients with normal range of blood parameters assessed by hemoglobin level, hematocrit level, leukocyte level, thrombocyte level, HbA1c level, kidney function and liver function
The blood parameters such as hemoglobin, hematocrit, leukocyte, thrombocyte, HbA1c, kidney function and liver function normal range is measured according to international standard
Measured: From enrollment to 3 months after treatment
Number of participants with improved Mini mental status examination, mini cog and AD8
Participants achieved a response if they have improvement of MMSE score, mini cog score and AD8 score
Measured: from enrollment to 3 months after treatment
Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels
Participants achieved a response if there is a decrease in GFAP levels
Measured: from enrollment to 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baermed
- Sponsor type
- University, hospital or other
- Collaborators
- Tarumanagara University, panti werda hana, LPPT TARUMANAGARA
- Responsible party
- Sponsor
- Investigators
- Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ, Principal investigator, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632470
- Sponsor's protocol ID
- 018-UTHREC/UNTAR/VIII/2024
- Status last verified
- Sep 2024
- First submitted
- 7 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Case Report Form (all collected IPD)
Publications
Chiu EC, Chien TH, Lee YC. Measurement Equivalence between the Original and Estimated Mini-Mental State Examination in People with Dementia. Int J Environ Res Public Health. 2021 Jul 17;18(14):7616. doi: 10.3390/ijerph18147616.
PubMed 34300067Myrberg K, Hyden LC, Samuelsson C. The mini-mental state examination (MMSE) from a language perspective: an analysis of test interaction. Clin Linguist Phon. 2020 Jul 2;34(7):652-670. doi: 10.1080/02699206.2019.1687757. Epub 2019 Nov 18.
PubMed 31739693Arevalo-Rodriguez I, Smailagic N, Roque I Figuls M, Ciapponi A, Sanchez-Perez E, Giannakou A, Pedraza OL, Bonfill Cosp X, Cullum S. Mini-Mental State Examination (MMSE) for the detection of Alzheimer's disease and other dementias in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2015 Mar 5;2015(3):CD010783. doi: 10.1002/14651858.CD010783.pub2.
PubMed 25740785Thanaskody K, Jusop AS, Tye GJ, Wan Kamarul Zaman WS, Dass SA, Nordin F. MSCs vs. iPSCs: Potential in therapeutic applications. Front Cell Dev Biol. 2022 Nov 2;10:1005926. doi: 10.3389/fcell.2022.1005926. eCollection 2022.
PubMed 36407112Lee C, Kim M, Han J, Yoon M, Jung Y. Mesenchymal Stem Cells Influence Activation of Hepatic Stellate Cells, and Constitute a Promising Therapy for Liver Fibrosis. Biomedicines. 2021 Nov 2;9(11):1598. doi: 10.3390/biomedicines9111598.
PubMed 34829827Teixeira FG, Panchalingam KM, Assuncao-Silva R, Serra SC, Mendes-Pinheiro B, Patricio P, Jung S, Anjo SI, Manadas B, Pinto L, Sousa N, Behie LA, Salgado AJ. Modulation of the Mesenchymal Stem Cell Secretome Using Computer-Controlled Bioreactors: Impact on Neuronal Cell Proliferation, Survival and Differentiation. Sci Rep. 2016 Jun 15;6:27791. doi: 10.1038/srep27791.
PubMed 27301770Willis CM, Nicaise AM, Hamel R, Pappa V, Peruzzotti-Jametti L, Pluchino S. Harnessing the Neural Stem Cell Secretome for Regenerative Neuroimmunology. Front Cell Neurosci. 2020 Nov 5;14:590960. doi: 10.3389/fncel.2020.590960. eCollection 2020.
PubMed 33250716Park JH, Jung SJ, Lee LJ, Rhu J, Bae SH. Impact of nonpharmacological interventions on cognitive impairment in women with breast cancer: A systematic review and meta-analysis. Asia Pac J Oncol Nurs. 2023 Mar 1;10(4):100212. doi: 10.1016/j.apjon.2023.100212. eCollection 2023 Apr.
PubMed 37095894Treanor CJ, McMenamin UC, O'Neill RF, Cardwell CR, Clarke MJ, Cantwell M, Donnelly M. Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment. Cochrane Database Syst Rev. 2016 Aug 16;2016(8):CD011325. doi: 10.1002/14651858.CD011325.pub2.
PubMed 27529826Hafiz R, Alajlani L, Ali A, Algarni GA, Aljurfi H, Alammar OAM, Ashqan MY, Alkhashan A. The Latest Advances in the Diagnosis and Treatment of Dementia. Cureus. 2023 Dec 14;15(12):e50522. doi: 10.7759/cureus.50522. eCollection 2023 Dec.
PubMed 38222245Salomone S, Caraci F, Leggio GM, Fedotova J, Drago F. New pharmacological strategies for treatment of Alzheimer's disease: focus on disease modifying drugs. Br J Clin Pharmacol. 2012 Apr;73(4):504-17. doi: 10.1111/j.1365-2125.2011.04134.x.
PubMed 22035455Pierre G. Neurodegenerative disorders and metabolic disease. Arch Dis Child. 2013 Aug;98(8):618-24. doi: 10.1136/archdischild-2012-302840. Epub 2013 May 22.
PubMed 23698595Zriek F, Di Battista JA, Alaaeddine N. Mesenchymal Stromal Cell Secretome: Immunomodulation, Tissue Repair and Effects on Neurodegenerative Conditions. Curr Stem Cell Res Ther. 2021;16(6):656-669. doi: 10.2174/1574888X16666210202145639.
PubMed 33530914Guo J, Huang X, Dou L, Yan M, Shen T, Tang W, Li J. Aging and aging-related diseases: from molecular mechanisms to interventions and treatments. Signal Transduct Target Ther. 2022 Dec 16;7(1):391. doi: 10.1038/s41392-022-01251-0.
PubMed 36522308Morrone A, Donini LM, Scardella P, Piombo L, Pinto A, Giusti AM, Neri B, Hagedorn T, Proietti AR, Cataldi S, Cucinotta D, Di Bella G, Barbagallo M, Cannella C; Gruppo di Lavoro MEG. [Malnutrition in the elderly: clinical features, psychological and social determinants. Preliminary results]. Ann Ig. 2011 Mar-Apr;23(2):161-72. Italian.
PubMed 21770232
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility and Safety of Human Umbilical Cord Mesenchymal Stem Cell Secretome in Moderate Neurocognitive Impairment (Dementia)
- ClinicalTrials.gov ID
- NCT06632470
- Acronym / sponsor ID
- 018-UTHREC/UNTAR/VIII/2024
- Conditions
- Dementia, Moderate Dementia
- Keywords
- dementia, moderate dementia, neurocognitive impairment, secretome, HUCSMC, stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- BaermedUniversity, hospital or other
- Collaborators
- Tarumanagara University, panti werda hana, LPPT TARUMANAGARA
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Oct 2024 (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 goal of this clinical trial if to learn if Human Umbilical Cord Mesenchymal Stem Cell (HUCMSC) derived secretome injection is safe and effective in patient with moderate dementia. The main questions it aims to answer are:
- Is HUCMSC derived secretome safe to be use as a therapy in patients with moderate dementia?
- How does HUCMSC derived secretome affect pro inflammatory and anti inflammatory cytokine (IL-6 and TNF alfa) in patient with moderate dementia?
- What is the relationship between HUCMSC derived secretome therapy with mini mental state examination? Researchers will compare the intervention group (patients who are injected with HUCMSC derived secretome) and control group (patients who are only monitored)
Participants will
- Be injected with HUCMSC derived secretome or Vitamin B12 every two weeks for 4 months
- Follow up visit to review treatment progress on 3rd months (2 weeks post treatment), 7th months (3 months post treatment) and participants will do several blood test and mental examination
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secretome injection | Experimental | Drug: Secretome injectionpatient will receive secretome injection every two weeks for four months |
| Vitamin B12 | Placebo comparator | Drug: Vitamin B12 Injectionpatient will receive 1 ampule of vitamin b12 every two weeks for 4 months |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age \> 60 years old
- Patient diagnosed with dementia confirmed by psychiatrist or neurologist based on DSM-4 or ICD 10
- Patient with Mini-Mental State Examination (MMSE) between 10 to 20 indicating moderate cognitive impairment
- Patient is in stable condition without life threatening disease or uncontrolled medical condition
- Patient undergoing stable dose treatment for other medical condition at least 4 months before the trial
Key exclusion criteria (8 listed)
- Patient has dementia due to other medical condition such as severe head trauma, brain infection or history of drug abuse
- Patient with uncontrolled medical condition such as severe cardiovascular disease, chronic lung disease, cancer, or systemic infection
- Patient with severe psychiatry disorder such as schizophrenia and bipolar disorder
- Patient is receiving experimental drugs or participates in experimental studies for the last 30 days before the trial
- Patient who has allergy or hypersensitivity reaction towards secretome
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 |
|---|---|---|
| Secretome injectionAlso: secretome, hucmscPatient will receive 3 ml of secretome intramuscular injection every two weeks for four months | Drug | Secretome injection |
| Vitamin B12 InjectionPatient will receive 1 ampule of vitamin b 12 intramuscular injection as a placebo drug every two weeks for four months | Drug | Vitamin B12 |
Primary outcome
Number of moderate dementia patients with normal range of blood parameters assessed by hemoglobin level, hematocrit level, leukocyte level, thrombocyte level, HbA1c level, kidney function and liver function
Time frame: From enrollment to 3 months after treatment
The blood parameters such as hemoglobin, hematocrit, leukocyte, thrombocyte, HbA1c, kidney function and liver function normal range is measured according to international standard
Number of participants with improved Mini mental status examination, mini cog and AD8
Time frame: from enrollment to 3 months after treatment
Participants achieved a response if they have improvement of MMSE score, mini cog score and AD8 score
Number of participants with improved Glial Fibrillary Acid Protein (GFAP) levels
Time frame: from enrollment to 3 months after treatment
Participants achieved a response if there is a decrease in GFAP levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 34300067Chiu EC, Chien TH, Lee YC. Measurement Equivalence between the Original and Estimated Mini-Mental State Examination in People with Dementia. Int J Environ Res Public Health. 2021 Jul 17;18(14):7616. doi: 10.3390/ijerph18147616.
- Background: PubMed 31739693Myrberg K, Hyden LC, Samuelsson C. The mini-mental state examination (MMSE) from a language perspective: an analysis of test interaction. Clin Linguist Phon. 2020 Jul 2;34(7):652-670. doi: 10.1080/02699206.2019.1687757. Epub 2019 Nov 18.
- Background: PubMed 25740785Arevalo-Rodriguez I, Smailagic N, Roque I Figuls M, Ciapponi A, Sanchez-Perez E, Giannakou A, Pedraza OL, Bonfill Cosp X, Cullum S. Mini-Mental State Examination (MMSE) for the detection of Alzheimer's disease and other dementias in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2015 Mar 5;2015(3):CD010783. doi: 10.1002/14651858.CD010783.pub2.
- Background: PubMed 36407112Thanaskody K, Jusop AS, Tye GJ, Wan Kamarul Zaman WS, Dass SA, Nordin F. MSCs vs. iPSCs: Potential in therapeutic applications. Front Cell Dev Biol. 2022 Nov 2;10:1005926. doi: 10.3389/fcell.2022.1005926. eCollection 2022.
- Background: PubMed 34829827Lee C, Kim M, Han J, Yoon M, Jung Y. Mesenchymal Stem Cells Influence Activation of Hepatic Stellate Cells, and Constitute a Promising Therapy for Liver Fibrosis. Biomedicines. 2021 Nov 2;9(11):1598. doi: 10.3390/biomedicines9111598.
- Background: PubMed 27301770Teixeira FG, Panchalingam KM, Assuncao-Silva R, Serra SC, Mendes-Pinheiro B, Patricio P, Jung S, Anjo SI, Manadas B, Pinto L, Sousa N, Behie LA, Salgado AJ. Modulation of the Mesenchymal Stem Cell Secretome Using Computer-Controlled Bioreactors: Impact on Neuronal Cell Proliferation, Survival and Differentiation. Sci Rep. 2016 Jun 15;6:27791. doi: 10.1038/srep27791.
- Background: PubMed 33250716Willis CM, Nicaise AM, Hamel R, Pappa V, Peruzzotti-Jametti L, Pluchino S. Harnessing the Neural Stem Cell Secretome for Regenerative Neuroimmunology. Front Cell Neurosci. 2020 Nov 5;14:590960. doi: 10.3389/fncel.2020.590960. eCollection 2020.
- Background: PubMed 37095894Park JH, Jung SJ, Lee LJ, Rhu J, Bae SH. Impact of nonpharmacological interventions on cognitive impairment in women with breast cancer: A systematic review and meta-analysis. Asia Pac J Oncol Nurs. 2023 Mar 1;10(4):100212. doi: 10.1016/j.apjon.2023.100212. eCollection 2023 Apr.
- Background: PubMed 27529826Treanor CJ, McMenamin UC, O'Neill RF, Cardwell CR, Clarke MJ, Cantwell M, Donnelly M. Non-pharmacological interventions for cognitive impairment due to systemic cancer treatment. Cochrane Database Syst Rev. 2016 Aug 16;2016(8):CD011325. doi: 10.1002/14651858.CD011325.pub2.
- Background: PubMed 38222245Hafiz R, Alajlani L, Ali A, Algarni GA, Aljurfi H, Alammar OAM, Ashqan MY, Alkhashan A. The Latest Advances in the Diagnosis and Treatment of Dementia. Cureus. 2023 Dec 14;15(12):e50522. doi: 10.7759/cureus.50522. eCollection 2023 Dec.
- Background: PubMed 22035455Salomone S, Caraci F, Leggio GM, Fedotova J, Drago F. New pharmacological strategies for treatment of Alzheimer's disease: focus on disease modifying drugs. Br J Clin Pharmacol. 2012 Apr;73(4):504-17. doi: 10.1111/j.1365-2125.2011.04134.x.
- Background: PubMed 23698595Pierre G. Neurodegenerative disorders and metabolic disease. Arch Dis Child. 2013 Aug;98(8):618-24. doi: 10.1136/archdischild-2012-302840. Epub 2013 May 22.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Case Report Form (all collected IPD)
Related trials for Dementia
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingPhase 2/3
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Agitation Associated With Alzheimer's Disease Dementia
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.
Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ principal investigator
Tarumanagara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Secretome injection and Vitamin B12 Injection in people with Dementia and Moderate Dementia, run by Baermed 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 6 inclusion and 8 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 9 Oct 2024. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Noer Saelan Dr. dr. Noer Saelan Tadjudin Sp.KJ (+628119211219, saelan_untar@yahoo.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of moderate dementia patients with normal range of blood parameters assessed by hemoglobin level, hematocrit level, leukocyte level, thrombocyte level, HbA1c level, kidney function and liver function (time frame: From enrollment to 3 months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06632470, which also lists 20 linked publications.
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 9 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.