Type 2 Diabetes With Renal ManifestationsPhase 1/2NCT04216849
Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
A Phase 1/2 study testing human umbilical cord mesenchymal stem cells and saline in people with Type 2 Diabetes With Renal Manifestations, run by Shanghai East Hospital at 1 site in China.
Trial summary
The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes With Renal Manifestations
- What is being tested?
- human umbilical cord mesenchymal stem cells and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jul 2022
- Phase
- Phase 1/2
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Diabetes duration≤20 years
- 18.5kg/m^2 ≤ BMI< 30 kg/m^2
- 7.5%≤HbA1C≤10%
- UACR≥30mg/gCr
- eGFR ≥45/milliliter/1.73m^2
Who cannot join
- Type 1 diabetes mellitus
- tumor history
- Other causes of chronic kidney disease
- Abnormal liver function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200124
Congrong Wang, MD, +86-021-38804518, wcr601@163.com
About this study
The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.
Read the detailed description
The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.We plan to recruit 54 subjects，which were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) at 0,8,16,24,32 week. The control group will be given the same dose of saline. Then centralization visit was conducted every 8 weeks until the 48th week.The primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(UACR). The secondary end points include HbA1C,plasma insulin and C-peptide, and insulin dose.
- Being tested
- human umbilical cord mesenchymal stem cells, saline
- Keywords
- human umbilical cord mesenchymal stem cells, type 2 diabetic nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord mesenchymal stem cellsBiological
human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
salineOther
Saline solution containing human serum albumin will be infused to the control group
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cells at 0,8,16,24,32 week. Receives: Biological: human umbilical cord mesenchymal stem cells |
| control group | Placebo comparator | The control group will be given the same dose of saline containing human albumin. Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
UACR
urinary albumin creatinine ratio
Measured: 48weeks after treatment
Secondary outcomes (4)
HbA1c
HbA1c
Measured: 48weeks after treatment
insulin/C peptide
serum level of insulin/C peptide
Measured: 48weeks after treatment
insulin dosage
insulin dosage
Measured: 48weeks after treatment
eGFR
estimated glomerular filtration rate
Measured: 48weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Jul 2020
- Primary completion1 Feb 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes With Renal ManifestationsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Zhongming Liu, MD, Principal investigator, Shanghai East Hospital, Shanghai Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216849
- Sponsor's protocol ID
- DFSC-2019(CR)-06
- Status last verified
- Jun 2020
- First submitted
- 17 Dec 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT04216849
- Acronym / sponsor ID
- DFSC-2019(CR)-06
- Keywords
- human umbilical cord mesenchymal stem cells, type 2 diabetic nephropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 3 Jan 2020 (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 study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.
Detailed description
The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.We plan to recruit 54 subjects，which were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) at 0,8,16,24,32 week. The control group will be given the same dose of saline. Then centralization visit was conducted every 8 weeks until the 48th week.The primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(UACR). The secondary end points include HbA1C,plasma insulin and C-peptide, and insulin dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: human umbilical cord mesenchymal stem cellsThe volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cells at 0,8,16,24,32 week. |
| control group | Placebo comparator | Other: salineThe control group will be given the same dose of saline containing human albumin. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus
- Diabetes duration≤20 years
- 18.5kg/m^2 ≤ BMI< 30 kg/m^2
- 7.5%≤HbA1C≤10%
- UACR≥30mg/gCr
Key exclusion criteria (4 listed)
- Type 1 diabetes mellitus
- tumor history
- Other causes of chronic kidney disease
- Abnormal liver function
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 cellshuman umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group | Biological | experimental group |
| salineSaline solution containing human serum albumin will be infused to the control group | Other | control group |
Primary outcome
UACR
Time frame: 48weeks after treatment
urinary albumin creatinine ratio
4 secondary outcomes
HbA1c
Time frame: 48weeks after treatment
insulin/C peptide
Time frame: 48weeks after treatment
insulin dosage
Time frame: 48weeks after treatment
eGFR
Time frame: 48weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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.
Zhongming Liu, MD principal investigator
Shanghai East Hospital, Shanghai Tongji University
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 human umbilical cord mesenchymal stem cells and saline in people with Type 2 Diabetes With Renal Manifestations, run by Shanghai East Hospital at 1 site in China.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Dec 2020. 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 China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Congrong Wang, MD (+86-021-38804518, wcr601@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UACR (time frame: 48weeks after treatment). 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 17 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.