Renal CirrhosisPhase 1/2NCT03460223
Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Kidney Fibrosis
A Phase 1/2 study testing MSC in people with Renal Cirrhosis, run by Nanjing Medical University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Cirrhosis
- What is being tested?
- MSC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to 1 Sep 2020
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Glomerular sclerosis ratio ≤ 50%.
- Renal tubulointerstitial fibrosis ratio ≤ 50%.
- Negative pregnancy test.
- Moderately active disease under standard treatment.
Who cannot join
- 1. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis
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.
Read the 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.
- Conditions
- Renal Cirrhosis
- Being tested
- MSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCBiological
conventional plus MSC or placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Conventional plus MSC treatment | Experimental | Not described Receives: Biological: MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
BUN
The evaluation of serum levels of BUN
Measured: 24 months
Cr
The evaluation of serum levels of Cr
Measured: 24 months
eGFR
The evaluation of serum levels of eGFR
Measured: 24 months
Cystatin C
The evaluation of serum levels of Cystatin C
Measured: 24 months
Urine protein
The evaluation of serum levels of Urine protein
Measured: 24 months
Secondary outcomes (10)
Hb
The evaluation of serum levels of Hb
Measured: 24 months
Hct
The evaluation of serum levels of Hct
Measured: 24 months
Ca
The evaluation of serum levels of Ca
Measured: 24 months
P
The evaluation of serum levels of P
Measured: 24 months
ALT
The evaluation of serum levels of ALT
Measured: 24 months
PTH
The evaluation of serum levels of PTH
Measured: 24 months
VitD
The evaluation of serum levels of VitD
Measured: 24 months
ALB
The evaluation of serum levels of ALB
Measured: 24 months
TC
The evaluation of serum levels of TC
Measured: 24 months
TG
The evaluation of serum levels of TG
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CirrhosisStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Lu, Nanjing Medical University
- Investigators
- Jinhai Tang, M.D, PH.D, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460223
- Sponsor's protocol ID
- NJLT006
- Status last verified
- Mar 2018
- First submitted
- 23 Feb 2018
- Last updated
- 9 Mar 2018
- 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 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Kidney Fibrosis
- ClinicalTrials.gov ID
- NCT03460223
- Acronym / sponsor ID
- NJLT006
- Conditions
- Renal Cirrhosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 9 Mar 2018 (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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional plus MSC treatment | Experimental | Biological: MSC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent.
- Glomerular sclerosis ratio ≤ 50%.
- Renal tubulointerstitial fibrosis ratio ≤ 50%.
- Negative pregnancy test.
- Moderately active disease under standard treatment.
Key exclusion criteria (1 listed)
- 1. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.
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 |
|---|---|---|
| MSCconventional plus MSC or placebo treatment | Biological | Conventional plus MSC treatment |
Primary outcome
BUN
Time frame: 24 months
The evaluation of serum levels of BUN
Cr
Time frame: 24 months
The evaluation of serum levels of Cr
eGFR
Time frame: 24 months
The evaluation of serum levels of eGFR
Cystatin C
Time frame: 24 months
The evaluation of serum levels of Cystatin C
Urine protein
Time frame: 24 months
The evaluation of serum levels of Urine protein
10 secondary outcomes
Hb
Time frame: 24 months
Hct
Time frame: 24 months
Ca
Time frame: 24 months
P
Time frame: 24 months
ALT
Time frame: 24 months
PTH
Time frame: 24 months
VitD
Time frame: 24 months
ALB
Time frame: 24 months
TC
Time frame: 24 months
TG
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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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.
Jinhai Tang, M.D, PH.D study chair
Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC in people with Renal Cirrhosis, run by Nanjing Medical University.
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 5 inclusion and 1 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 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Ling Lu, M.D, PH.D (86-025-68136053, lvling@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BUN (time frame: 24 months). The study lists 5 primary outcomes in all. 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 9 Mar 2018.