Diabetic Nephropathy Type 2Phase 1/2NCT07396155
Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
A Phase 1/2 study testing Umbilical Cord Mesenchymal Stem Cells in people with Diabetic Nephropathy Type 2, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65 years. The primary questions the study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetic Nephropathy Type 2
- What is being tested?
- Umbilical Cord Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2026to Oct 2027
- Phase
- Phase 1/2
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 2 Diabetes Mellitus (T2DM)
- Aged between 40 and 65 years
- Diagnosed with chronic kidney disease (CKD) stage III or IV, defined as estimated GFR (eGFR) between 15-60 mL/min/1.73 m² (using CKD-EPI formula)
- Renal biopsy showing diabetic nephropathy type IIa-IV
- Presence of proteinuria, with urine albumin-to-creatinine ratio (UACR) between 30-3000 mg/g (spot morning urine sample)
- Controlled diabetes, defined as HbA1c <10.0% during screening
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- Blood pressure within the range of: Systolic 100-160 mmHg, Diastolic 60-100 mmHg
- On stable standard therapy for diabetic nephropathy (e.g. ACE inhibitors or ARBs) for at least 12 weeks prior to screening
- Willing to provide written informed consent and comply with all study procedures until completion
Who cannot join
- Active malignancy or history of cancer
- Active liver disease or abnormal liver function (ALT or AST ≥2× upper limit of normal)
- Hemoglobin <8 g/dL or platelet count <100,000/µL
- Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months
- Positive pregnancy test or currently breastfeeding (for women of reproductive age)
- Currently receiving immunosuppressive therapy equivalent to ≥20 mg/day prednisone
- History of participation in other stem cell research or therapy studies
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, 1 recruiting
- Recruiting
Dr. Sardjito General Hospital
Yogyakarta, 55284
Metalia Puspitasari, MD, +628116110283, puspitasarimetalia@gmail.com
Metalia Puspitasari, MD
About this study
The goal of this clinical trial is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65 years. The primary questions the study aims to answer are:
- Is UC-MSC therapy safe and well-tolerated when administered intra-renally in patients with diabetic nephropathy?
- Does UC-MSC therapy improve kidney function and modulate inflammatory markers over a 12-month follow-up-period?
Read more
This is a single-arm, open-label, prospective clinical trial. Participants will receive a one-time intra-renal injection of UC-MSC at a dose of 1 x 10⁶ cells/kg body weight.
Participants will attend scheduled follow-up visits at 1, 3, 6, 9, and 12 months post-injections for evaluation of:
- Renal function (eGFR, serum creatinine, and urine albumin-creatinine ratio)
- Inflammatory markers (TNF-α, IL-10)
- Safety outcomes including early and late adverse events
The results will be compared to baseline measurements to assess changes after the intervention.
If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Read the detailed description
Diabetic nephropathy (DN) is one of the most common microvascular complications of diabetes mellitus and a leading cause of end-stage renal disease worldwide. Despite current standard therapies, many patients continue to experience progressive decline in renal function. As inflammation and immune dysregulation are increasingly recognized as contributors to DN pathogenesis, novel therapeutic strategies targeting these mechanisms are being explored.
Mesenchymal stem cells (MSCs), particularly those derived from umbilical cord tissue, have shown promising anti-inflammatory and regenerative effects in preclinical studies of kidney disease. Their immunomodulatory properties, low immunogenicity, and ease of collection make them a compelling option for cell-based therapies.
This clinical trial aims to evaluate the safety and potential therapeutic benefit of allogeneic umbilical cord-derived MSCs administered via intra-renal injection in individuals with diabetic nephropathy. The study is designed to provide early human data on the feasibility of using UC-MSCs as an adjunctive therapy in DN management. By assessing changes in renal function and inflammatory biomarkers over time, the trial seeks to explore the biological impact of UC-MSC therapy in this population.
This research represents an important step toward developing cell-based interventions for chronic kidney disease, particularly in settings where conventional treatments are insufficient. The findings are expected to contribute valuable data to the growing field of regenerative nephrology.
- Conditions
- Diabetic Nephropathy Type 2
- Being tested
- Umbilical Cord Mesenchymal Stem Cells
- Keywords
- Umbilical Cord Mesenchymal Stem Cell, Diabetic Nephropathy, Kidney Disease, Intra-renal Injection, TNF-alpha, IL-10, Glomerular Filtration Rate, eGFR, Regenerative Medicine, Mesenchymal Stem Cells, UC-MSC
- Medical subject headings
- Diabetic Nephropathies, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Mesenchymal Stem CellsBiological
This intervention consists of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) administered under imaging guidance. The dose administered is 1 × 10⁶ cells per kilogram of body weight.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSC treatment group | Experimental | Participants will receive a single intra-renal injection of UC-MSCs (1 × 10⁶ cells/kg BW), followed by a 12-month monitoring period for safety and renal function outcomes. Receives: Biological: Umbilical Cord Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Serious Adverse Events
Safety is assessed by recording the number and percentage of participants experiencing any adverse events (AEs), including both local and systemic reactions.
Measured: From baseline up to 12 months post-injection
Secondary outcomes (3)
Change in Estimated Glomerular Filtration Rate (eGFR)
Calculated using the CKD-EPI 2021 formula
Measured: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Change in Serum Creatinine
Measured in mg/dL. Collected via venous blood samples
Measured: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Change in Urine Albumin-to-Creatinine Ratio (UACR)
Measured in mg/g from morning spot urine samples
Measured: Baseline and at 1, 3, 6, 9, and 12 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 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- More trials run by PT. Prodia Stem Cell 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Sardjito General Hospital, Yogyakarta, Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396155
- Sponsor's protocol ID
- CT/DN/01/2025
- Status last verified
- Jun 2025
- First submitted
- 7 Jul 2025
- Last updated
- 9 Feb 2026
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07396155
- Acronym / sponsor ID
- CT/DN/01/2025
- Conditions
- Diabetic Nephropathy Type 2
- Keywords
- Umbilical Cord Mesenchymal Stem Cell, Diabetic Nephropathy, Kidney Disease, Intra-renal Injection, TNF-alpha, IL-10, Glomerular Filtration Rate, eGFR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Sardjito General Hospital, Yogyakarta, Indonesia
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 9 Feb 2026 (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 is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65 years. The primary questions the study aims to answer are:
- Is UC-MSC therapy safe and well-tolerated when administered intra-renally in patients with diabetic nephropathy?
- Does UC-MSC therapy improve kidney function and modulate inflammatory markers over a 12-month follow-up-period?
This is a single-arm, open-label, prospective clinical trial. Participants will receive a one-time intra-renal injection of UC-MSC at a dose of 1 x 10⁶ cells/kg body weight.
Participants will attend scheduled follow-up visits at 1, 3, 6, 9, and 12 months post-injections for evaluation of:
- Renal function (eGFR, serum creatinine, and urine albumin-creatinine ratio)
- Inflammatory markers (TNF-α, IL-10)
- Safety outcomes including early and late adverse events
The results will be compared to baseline measurements to assess changes after the intervention.
If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Detailed description
Diabetic nephropathy (DN) is one of the most common microvascular complications of diabetes mellitus and a leading cause of end-stage renal disease worldwide. Despite current standard therapies, many patients continue to experience progressive decline in renal function. As inflammation and immune dysregulation are increasingly recognized as contributors to DN pathogenesis, novel therapeutic strategies targeting these mechanisms are being explored.
Mesenchymal stem cells (MSCs), particularly those derived from umbilical cord tissue, have shown promising anti-inflammatory and regenerative effects in preclinical studies of kidney disease. Their immunomodulatory properties, low immunogenicity, and ease of collection make them a compelling option for cell-based therapies.
This clinical trial aims to evaluate the safety and potential therapeutic benefit of allogeneic umbilical cord-derived MSCs administered via intra-renal injection in individuals with diabetic nephropathy. The study is designed to provide early human data on the feasibility of using UC-MSCs as an adjunctive therapy in DN management. By assessing changes in renal function and inflammatory biomarkers over time, the trial seeks to explore the biological impact of UC-MSC therapy in this population.
This research represents an important step toward developing cell-based interventions for chronic kidney disease, particularly in settings where conventional treatments are insufficient. The findings are expected to contribute valuable data to the growing field of regenerative nephrology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC-MSC treatment group | Experimental | Biological: Umbilical Cord Mesenchymal Stem CellsParticipants will receive a single intra-renal injection of UC-MSCs (1 × 10⁶ cells/kg BW), followed by a 12-month monitoring period for safety and renal function outcomes. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with Type 2 Diabetes Mellitus (T2DM)
- Aged between 40 and 65 years
- Diagnosed with chronic kidney disease (CKD) stage III or IV, defined as estimated GFR (eGFR) between 15-60 mL/min/1.73 m² (using CKD-EPI formula)
- Renal biopsy showing diabetic nephropathy type IIa-IV
- Presence of proteinuria, with urine albumin-to-creatinine ratio (UACR) between 30-3000 mg/g (spot morning urine sample)
Key exclusion criteria (7 listed)
- Active malignancy or history of cancer
- Active liver disease or abnormal liver function (ALT or AST ≥2× upper limit of normal)
- Hemoglobin <8 g/dL or platelet count <100,000/µL
- Serious or unstable cerebrovascular or cardiovascular conditions within the last 6 months
- Positive pregnancy test or currently breastfeeding (for women of reproductive age)
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 |
|---|---|---|
| Umbilical Cord Mesenchymal Stem CellsThis intervention consists of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) administered under imaging guidance. The dose administered is 1 × 10⁶ cells per kilogram of body weight. | Biological | UC-MSC treatment group |
Primary outcome
Incidence of Adverse Events and Serious Adverse Events
Time frame: From baseline up to 12 months post-injection
Safety is assessed by recording the number and percentage of participants experiencing any adverse events (AEs), including both local and systemic reactions.
3 secondary outcomes
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Change in Serum Creatinine
Time frame: Baseline and at 1, 3, 6, 9, and 12 months after treatment
Change in Urine Albumin-to-Creatinine Ratio (UACR)
Time frame: Baseline and at 1, 3, 6, 9, and 12 months after treatment
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 9 Feb 2026.
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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 1/2 study testing Umbilical Cord Mesenchymal Stem Cells in people with Diabetic Nephropathy Type 2, run by PT. Prodia Stem Cell 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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Feb 2026. 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 combined 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.
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 Metalia Puspitasari, MD (+628116110283, puspitasarimetalia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events and Serious Adverse Events (time frame: From baseline up to 12 months post-injection). 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 9 Feb 2026.