Kidney TransplantPhase 1/2NCT00659620
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
A Phase 1/2 study testing mesenchymal stem cell in people with Kidney Transplant and Chronic Allograft Nephropathy, run by Fuzhou General Hospital at 1 site in China.
Trial summary
Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing properties. the investigators will infuse expanded MSC into patients who develop Chronic Allograft Nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Transplant, Chronic Allograft Nephropathy
- What is being tested?
- mesenchymal stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2008to May 2010
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recipients of a renal allograft, Male and female patients age 18 to 60 years of age.
- Ability to provide written informed consent.
- The serum creatinine form 176umol/L(2mg/ml) to 440umol/L(5mg/ml)
- Renal biopsy Criteria: chronic allograft nephropathy (Banff I-II).
- Immunosuppressant:CNI and MMF and Sirolimus
- Written informed consent, compliant with local regulations.
Who cannot join
- Recipients with leucopenia (WBC < 3000/mm³), thrombocytopenia (Thr < 100.000/mm³),or hyperlipidemia (Tot Chol > 300 mg/dl or Triglycerides > 300 mg/dl).
- Recipients of multiple organs.
- Pregnant women.
- Previous history of malignancy
- Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
- Evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months.
- Inadequate compliance to treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuzhou General Hospital
Fuzhou, Fujian, 350025
Jianming Tan T Jianming, professor, 008613375918000, doctortjm@YAHOO.COM
About this study
Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing properties. the investigators will infuse expanded MSC into patients who develop Chronic Allograft Nephropathy. The purpose of this study is to find out MSC is more effective in preventing organ rejection and maintaining kidney function.
Read the detailed description
Kidney transplantation is a common procedure in hospitals, but organ rejection and chronic nephrotoxicity are potential problems for the patient. Approximately ninety percent of the protocol biopsies of renal allografts, performed at 18 months post transplantation, show histological lesions of chronic calcineurin nephrotoxicity. Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Some patient in this study will also receive two infusions of expanded MSC. This study will evaluate the safety and effectiveness of MSC infusions in patients .
This study will last 2 years. Participants will be randomly assigned to receive either the full immunosuppressive therapy and MSC infusions (Group 1) or immunosuppressive therapy alone (Group 2). Patients will undergo MSC infusions at the start of the study on Day 0. One year post- infusions, patients will be evaluated. At Months 12 participants will undergo kidney biopsies. Blood collection will occur at regular intervals, Serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function will be evaluated.
- Conditions
- Kidney Transplant, Chronic Allograft Nephropathy
- Being tested
- mesenchymal stem cell
- Keywords
- Kidney Transplant, Chronic Allograft Nephropathy, Mesenchymal Stem Cell infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stem cellBiological
Also called MMF FK506
transplantation of mesenchymal stem cell
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | transplantation of mesenchymal stem cell Receives: Biological: mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine and creatinine clearance rate
Measured: 5
Secondary outcomes (4)
Patient and graft survival [ Time Frame: At 1 years post-transplant ].
Measured: 5
The proportion of renal biopsy after 12 months
Measured: 2
The incidence of infectious complications
Measured: 5
Incidence of adverse events associated with MSC and immunosuppression
Measured: 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2008 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jianming Tan T Jianming, professor, Principal investigator, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659620
- Sponsor's protocol ID
- fuzhough0712
- Other IDs
- fuzhough0712
- Status last verified
- Apr 2008
- First submitted
- 14 Apr 2008
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Allograft Nephropathy
- ClinicalTrials.gov ID
- NCT00659620
- Acronym / sponsor ID
- fuzhough0712
- Conditions
- Kidney Transplant, Chronic Allograft Nephropathy
- Keywords
- Kidney Transplant, Chronic Allograft Nephropathy, Mesenchymal Stem Cell infusion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2008 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 16 Apr 2008 (estimated)
- 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.
Mesenchymal Stem Cell (MSC) have been shown to have immunosuppressive and repairing properties. the investigators will infuse expanded MSC into patients who develop Chronic Allograft Nephropathy. The purpose of this study is to find out MSC is more effective in preventing organ rejection and maintaining kidney function.
Detailed description
Kidney transplantation is a common procedure in hospitals, but organ rejection and chronic nephrotoxicity are potential problems for the patient. Approximately ninety percent of the protocol biopsies of renal allografts, performed at 18 months post transplantation, show histological lesions of chronic calcineurin nephrotoxicity. Mesenchymal Stem Cell (MSC) has been shown to have immunosuppressive and repairing properties. Some patient in this study will also receive two infusions of expanded MSC. This study will evaluate the safety and effectiveness of MSC infusions in patients .
This study will last 2 years. Participants will be randomly assigned to receive either the full immunosuppressive therapy and MSC infusions (Group 1) or immunosuppressive therapy alone (Group 2). Patients will undergo MSC infusions at the start of the study on Day 0. One year post- infusions, patients will be evaluated. At Months 12 participants will undergo kidney biopsies. Blood collection will occur at regular intervals, Serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: mesenchymal stem celltransplantation of mesenchymal stem cell |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Recipients of a renal allograft, Male and female patients age 18 to 60 years of age.
- Ability to provide written informed consent.
- The serum creatinine form 176umol/L(2mg/ml) to 440umol/L(5mg/ml)
- Renal biopsy Criteria: chronic allograft nephropathy (Banff I-II).
- Immunosuppressant:CNI and MMF and Sirolimus
Key exclusion criteria (7 listed)
- Recipients with leucopenia (WBC < 3000/mm³), thrombocytopenia (Thr < 100.000/mm³),or hyperlipidemia (Tot Chol > 300 mg/dl or Triglycerides > 300 mg/dl).
- Recipients of multiple organs.
- Pregnant women.
- Previous history of malignancy
- Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
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 |
|---|---|---|
| mesenchymal stem cellAlso: MMF FK506transplantation of mesenchymal stem cell | Biological | 1 |
Primary outcome
Creatinine and creatinine clearance rate
Time frame: 5
4 secondary outcomes
Patient and graft survival [ Time Frame: At 1 years post-transplant ].
Time frame: 5
The proportion of renal biopsy after 12 months
Time frame: 2
The incidence of infectious complications
Time frame: 5
Incidence of adverse events associated with MSC and immunosuppression
Time frame: 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2008.
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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.
Jianming Tan T Jianming, professor principal investigator
Fuzhou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mesenchymal stem cell in people with Kidney Transplant and Chronic Allograft Nephropathy, run by Fuzhou General Hospital at 1 site in China.
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 6 inclusion and 7 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 16 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jianming Tan T Jianming, Professor (008613375918000, DOCTORTJM@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatinine and creatinine clearance rate (time frame: 5). 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 16 Apr 2008.