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

Primary Purpose

Type 2 Diabetes With Renal Manifestations

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

human umbilical cord mesenchymal stem cells

saline

About this trial

This is an interventional treatment trial for Type 2 Diabetes With Renal Manifestations focused on measuring human umbilical cord mesenchymal stem cells, type 2 diabetic nephropathy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (in brief):

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 (in brief):

Type 1 diabetes mellitus
tumor history
Other causes of chronic kidney disease
Abnormal liver function

Sites / Locations

Shanghai East HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

experimental group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

UACR

urinary albumin creatinine ratio

Secondary Outcome Measures

HbA1c

insulin/C peptide

serum level of insulin/C peptide

insulin dosage

eGFR

estimated glomerular filtration rate

Full Information

NCT ID

NCT04216849

First Posted

December 17, 2019

Last Updated

December 16, 2020

Sponsor

Shanghai East Hospital

Collaborators

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04216849

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

February 1, 2022 (Anticipated)

Study Completion Date

July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai East Hospital

Collaborators

Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes With Renal Manifestations

Keywords

human umbilical cord mesenchymal stem cells, type 2 diabetic nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

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.

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

human umbilical cord mesenchymal stem cells

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

saline

Intervention Description

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

Primary Outcome Measure Information:

Title

UACR

Description

urinary albumin creatinine ratio

Time Frame

48weeks after treatment

Secondary Outcome Measure Information:

Title

HbA1c

Description

HbA1c

Time Frame

48weeks after treatment

Title

insulin/C peptide

Description

serum level of insulin/C peptide

Time Frame

48weeks after treatment

Title

insulin dosage

Description

insulin dosage

Time Frame

48weeks after treatment

Title

eGFR

Description

estimated glomerular filtration rate

Time Frame

48weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria (in brief): 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 (in brief): Type 1 diabetes mellitus tumor history Other causes of chronic kidney disease Abnormal liver function

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Congrong Wang, MD

Phone

+86-021-38804518

wcr601@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhongming Liu, MD

Phone

+86-021-38804518

liu.zhongmin@tongji.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhongming Liu, MD

Organizational Affiliation

Shanghai East Hospital, Shanghai Tongji University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai East Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200124

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Congrong Wang, MD

Phone

+86-021-38804518

wcr601@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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