Type 2 Diabetes MellitusPhase 2NCT07144241
Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients
A Phase 2 study testing Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy and Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy in people with Type 2 Diabetes Mellitus, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This is an open-label randomized controlled trial with a pre-and-post-test control group design to evaluate the effect of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an adjunctive therapy on glycemic control and clinical outcomes in patients with Type 2 Diabetes Mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy and Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2025to 1 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Type 2 Diabetes Mellitus.
- Patients aged 40 to 65 years.
- Patients who are willing to participate in the study and sign the informed consent form after receiving a detailed explanation of the research procedure.
Who cannot join
- Patients with severe comorbidities that could affect the immune response, such as autoimmune diseases, malignancies, and severe infections.
- Patients currently undergoing anticoagulant therapy.
- Patients currently undergoing immunosuppressive therapy.
- Pregnant women, as the effects of exosome therapy on them have not been sufficiently studied.
- Patients with a history of severe allergies to components of the exosome therapy.
- Patients with CKD (Chronic Kidney Disease) on HD (Hemodialysis).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
UNIMUS Hospital
Semarang, Central Java
Dr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM, 085227700340, dr.yanuardani@gmail.com
About this study
This is an open-label randomized controlled trial with a pre-and-post-test control group design to evaluate the effect of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an adjunctive therapy on glycemic control and clinical outcomes in patients with Type 2 Diabetes Mellitus (T2DM). The study aims to determine if the addition of exosome therapy to standard care can improve glycemic parameters (fasting blood glucose, 2-hour postprandial glucose, HbA1c, and C-peptide), quality of life, and inflammatory biomarkers (IL-6, IL-10, D-dimer, and CRP). The study will involve 50 subjects, randomly allocated into two groups: an intervention group and a control group. The intervention group will receive standard T2DM therapy plus a combination of exosomes (1 vial Exo-HWS + 1 vial Exo-HUVEC). The control group will receive standard T2DM therapy plus 1 vial Exo-HWS. The study duration is from June to December 2025.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy, Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy
- Keywords
- DMT2, Mesenchymal Stromal/Stem Cells-Derived Exosomes, Glycemic Profile, Quality of Life, Inflammatory Biomarkers
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) TherapyBiological
The intervention group will receive standard DM therapy plus an exosome combination of 1 vial Exo-HWS + 1 vial Exo-HUVEC, administered monthly for three months via intravenous bolus injection.
Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) TherapyBiological
The control group will receive standard DM therapy plus 1 vial Exo-HWS, administered monthly for three months via intravenous bolus injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Intervention Group | Active comparator | Receives standard therapy for Diabetes Mellitus (DM) plus a combination of exosomes (1 vial Exo-HWS + 1 vial Exo-HUVEC).
Administered as a monthly intravenous bolus injection for three months Receives: Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy |
| Group 2: Control Group | Placebo comparator | Receives standard therapy for DM plus 1 vial of Exo-HWS.
Administered as a monthly intravenous bolus injection for three months. Receives: Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Blood Glucose (FBG)
Change in FBG levels from baseline to the end of the third month. Unit of Measurement: mg/dL
Measured: Baseline (Day 0) and End of the 3rd Month
2-Hour Postprandial Glucose
Change in 2-hour postprandial glucose levels from baseline to the end of the third month.
Unit of Measurement: mg/dL
Measured: Baseline (Day 0) and End of the 3rd Month
HbA1c
Change in HbA1c levels from baseline to the end of the third month. Unit of Measurement: %
Measured: Baseline (Day 0) and End of the 3rd Month
C-peptide
Change in C-peptide levels from baseline to the end of the third month. Unit of Measurement: ng/m
Measured: Baseline (Day 0) and End of the 3rd Month
Secondary outcomes (5)
Quality of Life using DQoL
Change in quality of life scores as measured by the Diabetes Quality of Life (DQoL) questionnaire from baseline to the end of the third month.
Unit of Measurement: Score
Measured: Baseline (Day 0) and End of the 3rd Month
IL-6
Change in Interleukin-6 (IL-6) levels from baseline to the end of the third month.
Unit of Measurement: mg/L
Measured: Baseline (Day 0) and End of the 3rd Month
IL-10
Change in Interleukin-10 (IL-10) levels from baseline to the end of the third month.
Unit of Measurement: mg/L
Measured: Baseline (Day 0) and End of the 3rd Month
D-dimer
Change in D-dimer levels from baseline to the end of the third month. Unit of Measurement: ng/mL
Measured: Baseline (Day 0) and End of the 3rd Month
CRP
Change in C-Reactive Protein (CRP) levels from baseline to the end of the third month.
Unit of Measurement: mg/L
Measured: Baseline (Day 0) and End of the 3rd Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label randomized controlled trial with a pre-and-post-test control group design. The study aims to compare the effectiveness of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an additional therapy for patients with Type 2 Diabetes Mellitus (T2DM). The study will recruit 50 subjects who meet the inclusion and exclusion criteria. These subjects will be randomly assigned to one of two groups Intervention Group: This group will receive standard T2DM therapy along with a combination of exosomes, specifically 1 vial of Exo-HWS and 1 vial of Exo-HUVEC. The exosome therapy will be administered as an intravenous bolus injection monthly, for three months. Control Group: This group will receive standard T2DM therapy plus 1 vial of Exo-HWS. This therapy will also be administered monthly, for three months, via intravenous bolus injection.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanuar Ardani, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144241
- Sponsor's protocol ID
- YArdani MSC-Exos T2DM
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no explicit plan to share Individual Participant Data (IPD) from this study. The research team's commitment to participant confidentiality is paramount. The informed consent form assures participants that their data and information will be kept confidential and will be used solely for the purpose of the research, education, and scientific development, without disclosing their identity. This approach aligns with the ethical clearance obtained for the study, which emphasizes protecting participant identity.
Publications
Li CJ, Xiao Y, Sun YC, He WZ, Liu L, Huang M, He C, Huang M, Chen KX, Hou J, Feng X, Su T, Guo Q, Huang Y, Peng H, Yang M, Liu GH, Luo XH. Senescent immune cells release grancalcin to promote skeletal aging. Cell Metab. 2021 Oct 5;33(10):1957-1973.e6. doi: 10.1016/j.cmet.2021.08.009. Epub 2021 Sep 9.
PubMed 34614408Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.
PubMed 32029601Lai RC, Yeo RW, Lim SK. Mesenchymal stem cell exosomes. Semin Cell Dev Biol. 2015 Apr;40:82-8. doi: 10.1016/j.semcdb.2015.03.001. Epub 2015 Mar 9.
PubMed 25765629Raposo G, Stoorvogel W. Extracellular vesicles: exosomes, microvesicles, and friends. J Cell Biol. 2013 Feb 18;200(4):373-83. doi: 10.1083/jcb.201211138.
PubMed 23420871American Diabetes Association. Standards of Medical Care in Diabetes-2021 Abridged for Primary Care Providers. Clin Diabetes. 2021 Jan;39(1):14-43. doi: 10.2337/cd21-as01. No abstract available.
PubMed 33551551Williams R, Karuranga S, Malanda B, Saeedi P, Basit A, Besancon S, Bommer C, Esteghamati A, Ogurtsova K, Zhang P, Colagiuri S. Global and regional estimates and projections of diabetes-related health expenditure: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108072. doi: 10.1016/j.diabres.2020.108072. Epub 2020 Feb 13.
PubMed 32061820
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) Therapy for Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT07144241
- Acronym / sponsor ID
- YArdani MSC-Exos T2DM
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- DMT2, Mesenchymal Stromal/Stem Cells-Derived Exosomes, Glycemic Profile, Quality of Life, Inflammatory Biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Aug 2025 (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 is an open-label randomized controlled trial with a pre-and-post-test control group design to evaluate the effect of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an adjunctive therapy on glycemic control and clinical outcomes in patients with Type 2 Diabetes Mellitus (T2DM). The study aims to determine if the addition of exosome therapy to standard care can improve glycemic parameters (fasting blood glucose, 2-hour postprandial glucose, HbA1c, and C-peptide), quality of life, and inflammatory biomarkers (IL-6, IL-10, D-dimer, and CRP). The study will involve 50 subjects, randomly allocated into two groups: an intervention group and a control group. The intervention group will receive standard T2DM therapy plus a combination of exosomes (1 vial Exo-HWS + 1 vial Exo-HUVEC). The control group will receive standard T2DM therapy plus 1 vial Exo-HWS. The study duration is from June to December 2025.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label randomized controlled trial with a pre-and-post-test control group design. The study aims to compare the effectiveness of Mesenchymal Stromal/Stem Cells-Derived Exosomes (MSC-Exos) as an additional therapy for patients with Type 2 Diabetes Mellitus (T2DM). The study will recruit 50 subjects who meet the inclusion and exclusion criteria. These subjects will be randomly assigned to one of two groups Intervention Group: This group will receive standard T2DM therapy along with a combination of exosomes, specifically 1 vial of Exo-HWS and 1 vial of Exo-HUVEC. The exosome therapy will be administered as an intravenous bolus injection monthly, for three months. Control Group: This group will receive standard T2DM therapy plus 1 vial of Exo-HWS. This therapy will also be administered monthly, for three months, via intravenous bolus injection.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Intervention Group | Active comparator | Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) TherapyReceives standard therapy for Diabetes Mellitus (DM) plus a combination of exosomes (1 vial Exo-HWS + 1 vial Exo-HUVEC). Administered as a monthly intravenous bolus injection for three months |
| Group 2: Control Group | Placebo comparator | Biological: Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) TherapyReceives standard therapy for DM plus 1 vial of Exo-HWS. Administered as a monthly intravenous bolus injection for three months. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with Type 2 Diabetes Mellitus.
- Patients aged 40 to 65 years.
- Patients who are willing to participate in the study and sign the informed consent form after receiving a detailed explanation of the research procedure.
Key exclusion criteria (6 listed)
- Patients with severe comorbidities that could affect the immune response, such as autoimmune diseases, malignancies, and severe infections.
- Patients currently undergoing anticoagulant therapy.
- Patients currently undergoing immunosuppressive therapy.
- Pregnant women, as the effects of exosome therapy on them have not been sufficiently studied.
- Patients with a history of severe allergies to components of the exosome 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 |
|---|---|---|
| Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) TherapyThe intervention group will receive standard DM therapy plus an exosome combination of 1 vial Exo-HWS + 1 vial Exo-HUVEC, administered monthly for three months via intravenous bolus injection. | Biological | Group 1: Intervention Group |
| Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) TherapyThe control group will receive standard DM therapy plus 1 vial Exo-HWS, administered monthly for three months via intravenous bolus injection. | Biological | Group 2: Control Group |
Primary outcome
Fasting Blood Glucose (FBG)
Time frame: Baseline (Day 0) and End of the 3rd Month
Change in FBG levels from baseline to the end of the third month. Unit of Measurement: mg/dL
2-Hour Postprandial Glucose
Time frame: Baseline (Day 0) and End of the 3rd Month
Change in 2-hour postprandial glucose levels from baseline to the end of the third month. Unit of Measurement: mg/dL
HbA1c
Time frame: Baseline (Day 0) and End of the 3rd Month
Change in HbA1c levels from baseline to the end of the third month. Unit of Measurement: %
C-peptide
Time frame: Baseline (Day 0) and End of the 3rd Month
Change in C-peptide levels from baseline to the end of the third month. Unit of Measurement: ng/m
5 secondary outcomes
Quality of Life using DQoL
Time frame: Baseline (Day 0) and End of the 3rd Month
IL-6
Time frame: Baseline (Day 0) and End of the 3rd Month
IL-10
Time frame: Baseline (Day 0) and End of the 3rd Month
D-dimer
Time frame: Baseline (Day 0) and End of the 3rd Month
CRP
Time frame: Baseline (Day 0) and End of the 3rd Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 34614408Li CJ, Xiao Y, Sun YC, He WZ, Liu L, Huang M, He C, Huang M, Chen KX, Hou J, Feng X, Su T, Guo Q, Huang Y, Peng H, Yang M, Liu GH, Luo XH. Senescent immune cells release grancalcin to promote skeletal aging. Cell Metab. 2021 Oct 5;33(10):1957-1973.e6. doi: 10.1016/j.cmet.2021.08.009. Epub 2021 Sep 9.
- Background: PubMed 32029601Kalluri R, LeBleu VS. The biology, function, and biomedical applications of exosomes. Science. 2020 Feb 7;367(6478):eaau6977. doi: 10.1126/science.aau6977.
- Background: PubMed 25765629Lai RC, Yeo RW, Lim SK. Mesenchymal stem cell exosomes. Semin Cell Dev Biol. 2015 Apr;40:82-8. doi: 10.1016/j.semcdb.2015.03.001. Epub 2015 Mar 9.
- Background: PubMed 23420871Raposo G, Stoorvogel W. Extracellular vesicles: exosomes, microvesicles, and friends. J Cell Biol. 2013 Feb 18;200(4):373-83. doi: 10.1083/jcb.201211138.
- Background: PubMed 33551551American Diabetes Association. Standards of Medical Care in Diabetes-2021 Abridged for Primary Care Providers. Clin Diabetes. 2021 Jan;39(1):14-43. doi: 10.2337/cd21-as01. No abstract available.
- Background: PubMed 32061820Williams R, Karuranga S, Malanda B, Saeedi P, Basit A, Besancon S, Bommer C, Esteghamati A, Ogurtsova K, Zhang P, Colagiuri S. Global and regional estimates and projections of diabetes-related health expenditure: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2020 Apr;162:108072. doi: 10.1016/j.diabres.2020.108072. Epub 2020 Feb 13.
- Individual participant dataSharing planned: No. There is no explicit plan to share Individual Participant Data (IPD) from this study. The research team's commitment to participant confidentiality is paramount. The informed consent form assures participants that their data and information will be kept confidential and will be used solely for the purpose of the research, education, and scientific development, without disclosing their identity. This approach aligns with the ethical clearance obtained for the study, which emphasizes protecting participant identity.
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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.
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 Stromal/Stem Cells-Derived Exosomes (Exo-HWS + 1 vial Exo-HUVEC) Therapy and Mesenchymal Stromal/Stem Cells-Derived Exosomes (Exo-HWS ) Therapy in people with Type 2 Diabetes Mellitus, 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Aug 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. dr. Yanuar Ardani, M.Kes, Sp.PD, K-PPM, FINASIM (085227700340, dr.yanuardani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Blood Glucose (FBG) (time frame: Baseline (Day 0) and End of the 3rd Month). The study lists 4 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 NCT07144241, which also lists 6 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 27 Aug 2025.