Arteriovenous Fistula StenosisPhase 1/2NCT07452822
Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease
A Phase 1/2 study testing Human umbilical cord mesenchymal stem cells injection and saline solution in people with Arteriovenous Fistula Stenosis, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd..
Trial summary
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arteriovenous Fistula Stenosis
- What is being tested?
- Human umbilical cord mesenchymal stem cells injection and saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 30 Mar 2028
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic nephropathy with estimated glomerular filtration rate (eGFR) < 15 mL/min·1.73m²;
- Requirement for creation of primary forearm cephalic vein-radial artery autologous arteriovenous fistula ;
- Vessel criteria: cephalic vein diameter ≥ 2.0 mm (after tourniquet inflation) and radial artery diameter ≥ 1.5 mm;
- Subject agrees to comply with the study treatment plan and visit schedule, is voluntarily enrolled, and has provided written informed consent.
Who cannot join
- Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension;
- Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow;
- Patients with a history of pacemaker implantation;
- Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products;
- Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;
- Subjects who have participated in, are currently participating in, or plan to participate in other interventional clinical trials within 30 days prior to screening or during the study period;
- Any other conditions deemed inappropriate by the investigator for enrollment in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Open-label and Single-arm Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
- Conditions
- Arteriovenous Fistula Stenosis
- Being tested
- Human umbilical cord mesenchymal stem cells injection, saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cells injectionBiological
Pahse 1: Patients will be enrolled into one of three cohorts to receive single injection of human umbilical cord mesenchymal stem cells injection(5×10^5 cells × vascular surface area (cm²), 2.5×10^6 cells × vascular surface area (cm²), 5×10^6 cells × vascular surface area (cm²)).
Phase 2: Based on the data obtained from Phase 1, the investigator will select one dose cohort to conduct study.
saline solutionOther
Phase 2: Saline solution will be given at the same quantity and following the same schedule
| Study group | Role | What they receive |
|---|---|---|
| MSCs treatment group | Experimental | Human umbilical cord mesenchymal stem cells injection is a human expanded umbilical cord mesenchymal stem cells suspension Receives: Biological: Human umbilical cord mesenchymal stem cells injection |
| Placebo-control group | Placebo comparator | Saline solution Receives: Other: saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Phase1: Exploration of dose-limiting toxicity (DLT) and the optimal dose for the phase 2 after the admistration of human umbilical cord mesenchymal stem cells injection.
Measured: Day 28
Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis
Phase2: Observation the primary patency rate and secondary patency rate of the AVF after administration of human umbilical cord mesenchymal stem cells
Measured: 3 months
Secondary outcomes (2)
Primary patency rate and secondary patency rate
Observation the primary patency rate and secondary patency rate of the AVF after surgery.
Measured: 1 year
Incidence of infection complications
Observation the incidence of infection complications after AVF surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start20 Feb 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula StenosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1 was a a prospective, single-arm, open-label study. Phase 2 was a prospective, randomized, placebo-controlled, and dose-escalation study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452822
- Sponsor's protocol ID
- TH-RD14-01
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label and Single-arm Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT07452822
- Acronym / sponsor ID
- TH-RD14-01
- Conditions
- Arteriovenous Fistula Stenosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 5 Mar 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.
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1 was a a prospective, single-arm, open-label study. Phase 2 was a prospective, randomized, placebo-controlled, and dose-escalation study.
| Arm | Type | Receives |
|---|---|---|
| MSCs treatment group | Experimental | Biological: Human umbilical cord mesenchymal stem cells injectionHuman umbilical cord mesenchymal stem cells injection is a human expanded umbilical cord mesenchymal stem cells suspension |
| Placebo-control group | Placebo comparator | Other: saline solutionSaline solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetic nephropathy with estimated glomerular filtration rate (eGFR) < 15 mL/min·1.73m²;
- Requirement for creation of primary forearm cephalic vein-radial artery autologous arteriovenous fistula ;
- Vessel criteria: cephalic vein diameter ≥ 2.0 mm (after tourniquet inflation) and radial artery diameter ≥ 1.5 mm;
- Subject agrees to comply with the study treatment plan and visit schedule, is voluntarily enrolled, and has provided written informed consent.
Key exclusion criteria (7 listed)
- Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension;
- Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow;
- Patients with a history of pacemaker implantation;
- Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products;
- Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody;
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 |
|---|---|---|
| Human umbilical cord mesenchymal stem cells injectionPahse 1: Patients will be enrolled into one of three cohorts to receive single injection of human umbilical cord mesenchymal stem cells injection(5×10^5 cells × vascular surface area (cm²), 2.5×10^6 cells × vascular surface area (cm²), 5×10^6 cells × vascular surface area (cm²)). Phase 2: Based on the data obtained from Phase 1, the investigator will select one dose cohort to conduct study. | Biological | MSCs treatment group |
| saline solutionPhase 2: Saline solution will be given at the same quantity and following the same schedule | Other | Placebo-control group |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Day 28
Phase1: Exploration of dose-limiting toxicity (DLT) and the optimal dose for the phase 2 after the admistration of human umbilical cord mesenchymal stem cells injection.
Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis
Time frame: 3 months
Phase2: Observation the primary patency rate and secondary patency rate of the AVF after administration of human umbilical cord mesenchymal stem cells
2 secondary outcomes
Primary patency rate and secondary patency rate
Time frame: 1 year
Incidence of infection complications
Time frame: 1 year
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 5 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human umbilical cord mesenchymal stem cells injection and saline solution in people with Arteriovenous Fistula Stenosis, run by Jiangsu Topcel-KH Pharmaceutical Co., Ltd..
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 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: opening soon, as of the sponsor's last update on 5 Mar 2026. 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?
Contact Jianhua Dong (02580864326, dongjianhua007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Day 28). The study lists 2 primary outcomes in all. 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 5 Mar 2026.