Diabetic Kidney DiseasePhase 2NCT07039318
Mesenchymal Stem Cell Therapy in Diabetic Kidney Disease-A Double-blind, Placebo-controlled, Randomized Clinical Trial
A Phase 2 study testing Mesenchymal stem cells in people with Diabetic Kidney Disease, run by National Institute of Blood and Marrow Transplant (NIBMT), Pakistan at 2 sites in Pakistan.
Trial summary
Diabetes had global prevalence of 9% in 2014 and is increasing alarmingly, affecting approximately 387 million people worldwide. It is strongly linked to complications, like chronic kidney failure, blindness and neurdegeneration. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Mesenchymal stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Dec 2022to 31 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between 18 and 75 years of age having Type-2 Diabetes with CKD stage 2,3 and 4: (eGFR 15-90 mL/min/1.73 m2).
Who cannot join
- Patients with a history of other comorbidities like previous myocardial infarction, pulmonary disease, pregnant females, unable to follow or return for evaluation.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
National Institute of Blood and Marrow Transplant (NIBMT), Pakistan/Armed Forces Bone Marrow Transplant Centre
Rawalpindi, 46000
Pak Emirates Military Hospital, Rawalpindi (PEMH)
Rawalpindi, 46000
About this study
Diabetes had global prevalence of 9% in 2014 and is increasing alarmingly, affecting approximately 387 million people worldwide. It is strongly linked to complications, like chronic kidney failure, blindness and neurdegeneration. From 1999-2006, prevalence of chronic kidney disease (CKD) stage 1-2 was 11.5%, and stage 3-4 was 58%, while its prevalence in Pakistan is 12.5%. CKD is a pathophysiological process with multiple etiologies, eventually resulting in irreversible nephron damage and leading to End Stage Renal Disease (ESRD), rendering the patient permanently dependent on Renal Replacement. In Pakistan, the prevalence of diabetic ESRD is 22%. Only supportive management is offered, resulting in either dialysis dependency or transplant. High CKD prevalence, renal replacement therapy and associated morbidity-mortality demands more effective and easier treatment option. We propose Mesenchymal Stem Cells (MSC) therapy for reversing the chronic kidney damage caused by type2 diabetes.
Read the detailed description
Diabetes cases increased from 108 million in 1980 to 422 million in 2014 worldwide. Its prevalence has risen more rapidly in low- and middle-income countries than in high-income countries. It has become the leading cause of blindness, kidney failure, heart attacks, stroke and amputation of lower limbs. Damage to kidneys due to high blood is a serious threat, over time they stop the filtration process blood, leading to Chronic Kidney Disease. Approximately 1 in 3 adults with diabetes has CKD, which leads to kidney failure in worst cases and the only options left for the patient are regular dialysis or kidney transplant. Both these options are usually scarce, unaffordable and unavailable in developing countries like Pakistan. In finding an easier and effective treatment option for CKD secondary to diabetes it was found that MSCs can stop tissue damage progression in CKD, this has been extensively investigated in preclinical studies till now. Bone marrow derived MSCs are multipotent, including hematopoietic stem cell, mesenchymal stromal cells and endothelial progenitor cell. MSCs have anti-inflammatory and antifibrotic properties and can suppress maturation, activation and proliferation of T, B and NK cells in vitro and down regulate immune response in vivo. Beneficial effects of MSCs are seen largely through immunomodulatory and paracrine mechanisms like production of growth factors and cytokines with immunosuppressive, anti-inflammatory, anti-apoptotic and proliferative effects. Cultured MSCs release large amounts of pro-angiogenic factor; vascular endothelial growth factor which facilitates glomerular and tubular recovery. MSC therapy in CKD-preclinical studies have shown that single dose of bone marrow-derived MSCs in rats decreased interstitial fibrosis, tubular atrophy, T-cell and macrophage infiltration, and the expression of inflammatory cytokines. This has been attributed to their paracrine immunomodulatory properties rather than long-term engraftment. MSCs also have the capacity to induce proliferation of renal glomerular and tubular cells and increase cellular survival. In preclinical studies injected MSCs secrete pro-angiogenic and trophic factors which enhance proliferation and decrease apoptosis of tubular cells. However, engraftment and trans-differentiation was not observed in the majority of the studies. Although there is a large gap between scientific knowledge and clinical translation for a safe and effective stem cell-based therapy, stem cells hold great promise for the treatment of CKD. We aim to study the efficacy of MSCs treatment in diabetic nephropathy CKD stage 2 and 3 due to type 2 Diabetes Mellitus. For this purpose, we have designed a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy of MSC therapy in chronic kidney disease.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Mesenchymal stem cells, Normal Saline (Placebo)
- Keywords
- diabetic kidney disease, mesenchymal stem cells, randomized controlled trial
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsBiological
Mesenchymal stem cells
Normal Saline (Placebo)Drug
Normal Saline (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells | Experimental | Mesenchymal stem cells (30 million cells) Receives: Biological: Mesenchymal stem cells |
| Normal Saline (Placebo) | Placebo comparator | Normal Saline (Placebo) Receives: Drug: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
isotopic DTPA Scan
Glomerular Filtration Rate using Renal isotope 99mTc-DTPA
Measured: To be carried out at enrollment and at six months' post-intervention
Secondary outcomes (1)
Glycosylated Hemoglobin level
Glycosylated Hemoglobin using HBA1c level in blood
Measured: To be carried out at baseline and at six months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Dec 2022
- Primary completion28 Feb 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional, double blind, randomized, controlled clinical trial where participants either receive mesenchymal stem cells (30 million cells) or placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
- Sponsor type
- Other government
- Collaborators
- Pak Emirates Military Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039318
- Sponsor's protocol ID
- MSC-CKD/2022
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell Therapy in Diabetic Kidney Disease-A Double-blind, Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07039318
- Acronym / sponsor ID
- MSC-CKD/2022
- Conditions
- Diabetic Kidney Disease
- Keywords
- diabetic kidney disease, mesenchymal stem cells, randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- National Institute of Blood and Marrow Transplant (NIBMT), PakistanOther government
- Collaborators
- Pak Emirates Military Hospital
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 26 Jun 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.
Diabetes had global prevalence of 9% in 2014 and is increasing alarmingly, affecting approximately 387 million people worldwide. It is strongly linked to complications, like chronic kidney failure, blindness and neurdegeneration. From 1999-2006, prevalence of chronic kidney disease (CKD) stage 1-2 was 11.5%, and stage 3-4 was 58%, while its prevalence in Pakistan is 12.5%. CKD is a pathophysiological process with multiple etiologies, eventually resulting in irreversible nephron damage and leading to End Stage Renal Disease (ESRD), rendering the patient permanently dependent on Renal Replacement. In Pakistan, the prevalence of diabetic ESRD is 22%. Only supportive management is offered, resulting in either dialysis dependency or transplant. High CKD prevalence, renal replacement therapy and associated morbidity-mortality demands more effective and easier treatment option. We propose Mesenchymal Stem Cells (MSC) therapy for reversing the chronic kidney damage caused by type2 diabetes.
Detailed description
Diabetes cases increased from 108 million in 1980 to 422 million in 2014 worldwide. Its prevalence has risen more rapidly in low- and middle-income countries than in high-income countries. It has become the leading cause of blindness, kidney failure, heart attacks, stroke and amputation of lower limbs. Damage to kidneys due to high blood is a serious threat, over time they stop the filtration process blood, leading to Chronic Kidney Disease. Approximately 1 in 3 adults with diabetes has CKD, which leads to kidney failure in worst cases and the only options left for the patient are regular dialysis or kidney transplant. Both these options are usually scarce, unaffordable and unavailable in developing countries like Pakistan. In finding an easier and effective treatment option for CKD secondary to diabetes it was found that MSCs can stop tissue damage progression in CKD, this has been extensively investigated in preclinical studies till now. Bone marrow derived MSCs are multipotent, including hematopoietic stem cell, mesenchymal stromal cells and endothelial progenitor cell. MSCs have anti-inflammatory and antifibrotic properties and can suppress maturation, activation and proliferation of T, B and NK cells in vitro and down regulate immune response in vivo. Beneficial effects of MSCs are seen largely through immunomodulatory and paracrine mechanisms like production of growth factors and cytokines with immunosuppressive, anti-inflammatory, anti-apoptotic and proliferative effects. Cultured MSCs release large amounts of pro-angiogenic factor; vascular endothelial growth factor which facilitates glomerular and tubular recovery. MSC therapy in CKD-preclinical studies have shown that single dose of bone marrow-derived MSCs in rats decreased interstitial fibrosis, tubular atrophy, T-cell and macrophage infiltration, and the expression of inflammatory cytokines. This has been attributed to their paracrine immunomodulatory properties rather than long-term engraftment. MSCs also have the capacity to induce proliferation of renal glomerular and tubular cells and increase cellular survival. In preclinical studies injected MSCs secrete pro-angiogenic and trophic factors which enhance proliferation and decrease apoptosis of tubular cells. However, engraftment and trans-differentiation was not observed in the majority of the studies. Although there is a large gap between scientific knowledge and clinical translation for a safe and effective stem cell-based therapy, stem cells hold great promise for the treatment of CKD. We aim to study the efficacy of MSCs treatment in diabetic nephropathy CKD stage 2 and 3 due to type 2 Diabetes Mellitus. For this purpose, we have designed a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy of MSC therapy in chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is an interventional, double blind, randomized, controlled clinical trial where participants either receive mesenchymal stem cells (30 million cells) or placebo.
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells | Experimental | Biological: Mesenchymal stem cellsMesenchymal stem cells (30 million cells) |
| Normal Saline (Placebo) | Placebo comparator | Drug: Normal Saline (Placebo)Normal Saline (Placebo) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients between 18 and 75 years of age having Type-2 Diabetes with CKD stage 2,3 and 4: (eGFR 15-90 mL/min/1.73 m2).
Key exclusion criteria (1 listed)
- Patients with a history of other comorbidities like previous myocardial infarction, pulmonary disease, pregnant females, unable to follow or return for evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cellsMesenchymal stem cells | Biological | Mesenchymal stem cells |
| Normal Saline (Placebo)Normal Saline (Placebo) | Drug | Normal Saline (Placebo) |
Primary outcome
isotopic DTPA Scan
Time frame: To be carried out at enrollment and at six months' post-intervention
Glomerular Filtration Rate using Renal isotope 99mTc-DTPA
1 secondary outcome
Glycosylated Hemoglobin level
Time frame: To be carried out at baseline and at six months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stem cells in people with Diabetic Kidney Disease, run by National Institute of Blood and Marrow Transplant (NIBMT), Pakistan at 2 sites in Pakistan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
isotopic DTPA Scan (time frame: To be carried out at enrollment and at six months' post-intervention). 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 26 Jun 2025.