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

• Sponsor: Nanjing Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03460223
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 29

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cirrhosis	Biological: MSC	Phase 1/Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis
• Anticipated Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Mar 1, 2020
• Anticipated Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conventional plus MSC treatment	Biological: MSC; conventional plus MSC or placebo treatment

Outcome Measures

Primary Outcome Measures

1. BUN [24 months]

   The evaluation of serum levels of BUN

2. Cr [24 months]

   The evaluation of serum levels of Cr

3. eGFR [24 months]

   The evaluation of serum levels of eGFR

4. Cystatin C [24 months]

   The evaluation of serum levels of Cystatin C

5. Urine protein [24 months]

   The evaluation of serum levels of Urine protein

Secondary Outcome Measures

1. Hb [24 months]

   The evaluation of serum levels of Hb

2. Hct [24 months]

   The evaluation of serum levels of Hct

3. Ca [24 months]

   The evaluation of serum levels of Ca

4. P [24 months]

   The evaluation of serum levels of P

5. ALT [24 months]

   The evaluation of serum levels of ALT

6. PTH [24 months]

   The evaluation of serum levels of PTH

7. VitD [24 months]

   The evaluation of serum levels of VitD

8. ALB [24 months]

   The evaluation of serum levels of ALB

9. TC [24 months]

   The evaluation of serum levels of TC

10. TG [24 months]

    The evaluation of serum levels of TG

Other Outcome Measures

1. Evaluation of renal fibrosis [24 months]

   The pathology decrease in grade of renal fibrosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nanjing Medical University

Investigators

• Study Chair: Jinhai Tang, M.D, PH.D, Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ling Lu, Principal Investigator, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT03460223
• Other Study ID Numbers: NJLT006
• First Posted: Mar 9, 2018
• Last Update Posted: Mar 9, 2018
• Last Verified: Mar 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fibrosis

Study Results

No Results Posted as of Mar 9, 2018