Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Kidney Fibrosis

Renal Cirrhosis Clinical Trial

Official title:

Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03460223
• Other study ID #: NJLT006
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: February 23, 2018
• Last updated: March 4, 2018
• Start date: April 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2018
• Source: Nanjing Medical University
• Contact: Ling Lu, M.D, PH.D
• Phone: 86-025-68136053
• Email: lvling[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In progressive kidney diseases, fibrosis represents the common pathway to end-stage kidney failure. The potential for stem cells to treat kidney failure was recently confirmed. Particularly, mesenchymal stem cell (MSC) has been demonstrated to protect kidney function and alleviating renal injury in these patients. Therefore, the investigators propose a hypothesis that MSCs (MSC) can also improve the disease conditions of kidney fibrosis patients, particularly reducing the decompensated conditions in these patients.

Description:

Kidney fibrosis represents the common pathway to end-stage kidney failure.The potential for stem cells to treat kidney failure was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as GVHD, kidyney injury and displayed good tolerance and efficiency. The purpose of this study is to learn whether and how MSCs (MSC) can improve the disease conditions in patients with kidney fibrosis. This study will also look at safety in these patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Written informed consent.

2. Glomerular sclerosis ratio = 50%.

3. Renal tubulointerstitial fibrosis ratio = 50%.

4. Negative pregnancy test.

5. Moderately active disease under standard treatment.

Exclusion Criteria:

1. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.

Related Conditions & MeSH terms

• Renal Cirrhosis

Intervention

Biological:
• MSC
conventional plus MSC or placebo treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of renal fibrosis	The pathology decrease in grade of renal fibrosis	24 months
Primary	BUN	The evaluation of serum levels of BUN	24 months
Primary	Cr	The evaluation of serum levels of Cr	24 months
Primary	eGFR	The evaluation of serum levels of eGFR	24 months
Primary	Cystatin C	The evaluation of serum levels of Cystatin C	24 months
Primary	Urine protein	The evaluation of serum levels of Urine protein	24 months
Secondary	Hb	The evaluation of serum levels of Hb	24 months
Secondary	Hct	The evaluation of serum levels of Hct	24 months
Secondary	Ca	The evaluation of serum levels of Ca	24 months
Secondary	P	The evaluation of serum levels of P	24 months
Secondary	ALT	The evaluation of serum levels of ALT	24 months
Secondary	PTH	The evaluation of serum levels of PTH	24 months
Secondary	VitD	The evaluation of serum levels of VitD	24 months
Secondary	ALB	The evaluation of serum levels of ALB	24 months
Secondary	TC	The evaluation of serum levels of TC	24 months
Secondary	TG	The evaluation of serum levels of TG	24 months