MedDataX Logo

Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy

NCT ID: NCT04216849

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes With Renal Manifestations

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

human umbilical cord mesenchymal stem cells type 2 diabetic nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental 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 cells at 0,8,16,24,32 week.

Group Type EXPERIMENTAL

human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group

control group

The control group will be given the same dose of saline containing human albumin.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

Saline solution containing human serum albumin will be infused to the control group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

human umbilical cord mesenchymal stem cells

human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group

Intervention Type BIOLOGICAL

saline

Saline solution containing human serum albumin will be infused to the control group

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Type 1 diabetes mellitus
* tumor history
* Other causes of chronic kidney disease
* Abnormal liver function
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

Shanghai East Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhongming Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital, Shanghai Tongji University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Congrong Wang, MD

Role: CONTACT

Phone: +86-021-38804518

Email: [email protected]

Zhongming Liu, MD

Role: CONTACT

Phone: +86-021-38804518

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Congrong Wang, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DFSC-2019(CR)-06

Identifier Type: -

Identifier Source: org_study_id