Kidney Disease, ChronicPhase 1/2NCT07240987
Mesenchymal Stem Cells for Chronic Kidney Diseases
A Phase 1/2 study testing 0.9% sodium chloride and MSCs in people with Kidney Disease, Chronic and Diabetic Kidney Disease (DKD), run by The First Affiliated Hospital of Air Force Medical University.
Trial summary
This study will evaluate the effect of intravenous injection of umbilical cord tissue derived mesenchymal stem cells (UMSCs) on the improvement of renal function in patients with chronic kidney disease (CKD) at stage 3 or 4, with the change of estimated glomerular filtration rate (eGFR) as the primary endpoint, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Chronic, Diabetic Kidney Disease (DKD), Hypertensive Nephropathy
- What is being tested?
- 0.9% sodium chloride and MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreement to participate in the trial and provision of signed written informed consent
- Pathological diagnosis of diabetic nephropathy or hypertensive renal damage
- 15 ≤ eGFR < 60 mL/min/1.73m², UACR > 300 mg/g
- Age ≥ 18 years
Who cannot join
- Extremely severe anemia (hemoglobin < 30 g/L)
- Received blood product transfusion therapy within 1 month
- Autosomal dominant or recessive polycystic kidney disease (ADPKD)
- History of kidney transplant or other solid organ transplant
- Active systemic or localized infection (e.g., pneumonia, osteomyelitis)
- Allergy to stem cells themselves or stem cell-related culture medium
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- History of allergic reaction to cell products (e.g., blood transfusion, platelets)
- History of coagulation disorders (thromboembolism, pulmonary embolism, deep vein thrombosis)
- History of malignancy or current malignant disease
- Elevated tumor markers (AFP, CEA, CA199, CA125, etc.)
- Pregnant women or women with plans for pregnancy within 3 months after MSC therapy
- Participation in drug-related clinical trials within the past 2 months
- Any form of drug abuse, mental illness, or other conditions considered by the investigator as potentially affecting the trial's validity or the subject's health
About this study
Official title: A Randomized Controlled Study of Mesenchymal Stem Cells in the Treatment of Chronic Kidney Diseases
This study will evaluate the effect of intravenous injection of umbilical cord tissue derived mesenchymal stem cells (UMSCs) on the improvement of renal function in patients with chronic kidney disease (CKD) at stage 3 or 4, with the change of estimated glomerular filtration rate (eGFR) as the primary endpoint, and other changes in renal function laboratory indicators, changes in other organ system function laboratory indicators, and adverse reaction events as secondary endpoints. This trial aims to further evaluate the efficacy and safety of UMCSs in CKD patients, and provide new insights into expanding the clinical treatment strategies, delaying the progression and improving the prognosis of CKD patients.
- Being tested
- 0.9% sodium chloride, MSCs
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetic Nephropathies, Hypertensive Nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% sodium chlorideDrug
The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection.
MSCsDrug
The experimental group will receive an intravenous injection of allogeneic MSCs at a dose of 1.0×10⁶ cells per kilogram, reconstituted with 250 mL of sodium chloride injection.
| Study group | Role | What they receive |
|---|---|---|
| DKD | Experimental | Not described Receives: Drug: MSCs |
| HN | Experimental | Not described Receives: Drug: MSCs |
| non-DKD | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride |
| non-HN | Placebo comparator | Not described Receives: Drug: 0.9% sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Efficacy Endpoints: Changes in eGFR, 24-hour urine protein, and UACR at 1, 3, 6, and 12 months will serve as primary endpoints to assess renal function improvement. Changes in other renal function parameters (e.g., quantitative urine protein, urine red blood cells, serum creatinine, cystatin C),and changes in other organ system function parameters (e.g., ECG/echocardiography, complete blood count, liver function, NT-proBNP, parathyroid hormone, 25-dihydroxyvitamin D, lymphocyte subsets) at 1, 3, 6, and 12 months will serve as secondary endpoints.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Air Force Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Jipeng, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240987
- Sponsor's protocol ID
- KY20242307
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Mesenchymal Stem Cells in the Treatment of Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT07240987
- Acronym / sponsor ID
- KY20242307
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Air Force Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 21 Nov 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 study will evaluate the effect of intravenous injection of umbilical cord tissue derived mesenchymal stem cells (UMSCs) on the improvement of renal function in patients with chronic kidney disease (CKD) at stage 3 or 4, with the change of estimated glomerular filtration rate (eGFR) as the primary endpoint, and other changes in renal function laboratory indicators, changes in other organ system function laboratory indicators, and adverse reaction events as secondary endpoints. This trial aims to further evaluate the efficacy and safety of UMCSs in CKD patients, and provide new insights into expanding the clinical treatment strategies, delaying the progression and improving the prognosis of CKD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DKD | Experimental | Drug: MSCs |
| HN | Experimental | Drug: MSCs |
| non-DKD | Placebo comparator | Drug: 0.9% sodium chloride |
| non-HN | Placebo comparator | Drug: 0.9% sodium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agreement to participate in the trial and provision of signed written informed consent
- Pathological diagnosis of diabetic nephropathy or hypertensive renal damage
- 15 ≤ eGFR < 60 mL/min/1.73m², UACR > 300 mg/g
- Age ≥ 18 years
Key exclusion criteria (13 listed)
- Extremely severe anemia (hemoglobin < 30 g/L)
- Received blood product transfusion therapy within 1 month
- Autosomal dominant or recessive polycystic kidney disease (ADPKD)
- History of kidney transplant or other solid organ transplant
- Active systemic or localized infection (e.g., pneumonia, osteomyelitis)
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 |
|---|---|---|
| 0.9% sodium chlorideThe control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection. | Drug | non-DKD, non-HN |
| MSCsThe experimental group will receive an intravenous injection of allogeneic MSCs at a dose of 1.0×10⁶ cells per kilogram, reconstituted with 250 mL of sodium chloride injection. | Drug | DKD, HN |
Primary outcome
Primary Outcome Measure
Time frame: From enrollment to the end of treatment at 12 months
Efficacy Endpoints: Changes in eGFR, 24-hour urine protein, and UACR at 1, 3, 6, and 12 months will serve as primary endpoints to assess renal function improvement. Changes in other renal function parameters (e.g., quantitative urine protein, urine red blood cells, serum creatinine, cystatin C),and changes in other organ system function parameters (e.g., ECG/echocardiography, complete blood count, liver function, NT-proBNP, parathyroid hormone, 25-dihydroxyvitamin D, lymphocyte subsets) at 1, 3, 6, and 12 months will serve as secondary endpoints.
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 24 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 0.9% sodium chloride and MSCs in people with Kidney Disease, Chronic and Diabetic Kidney Disease (DKD), run by The First Affiliated Hospital of Air Force Medical University.
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 4 inclusion and 13 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 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Primary Outcome Measure (time frame: From enrollment to the end of treatment at 12 months). 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 24 Dec 2025.