Renal TransplantationPhase 2NCT03478215
Mesenchymal Stromal Cells in Living Donor Kidney Transplantation
A Phase 2 study testing Mesenchymal Stromal Stem Cells (MSCs) Infusion in people with Renal Transplantation and Mesenchymal Stem Cells, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation, Mesenchymal Stem Cells
- What is being tested?
- Mesenchymal Stromal Stem Cells (MSCs) Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females from 18 to 65 years of age
- Planned to receive a primary kidney transplant from a living donor
- Low immunologic risk defined as
- No history of current or historical antidonor human leukocyte antigen (HLA) antibodies (DSA)
- Panel of Reactive Antibodies (PRA) <20%, historical
- Low risk for thrombotic events and normal prothrombin time, international normalized ratio (INR) and partial thromboplastin time
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- Women of child bearing potential have a negative serum pregnancy test prior to transplantation
- Women of child bearing potential (including perimenopausal women who have had a menstrual period within the previous 1 year) who agree to use 2 forms of effective birth control regimen (at least one of which is a barrier method) throughout the study period and for 6 weeks following the end of the study or the last dose of mycophenolate mofetil, whichever comes first.
- In the opinion of the investigator, the subject is capable of understanding and complying with the protocol.
- Subjects must have signed the informed consent document prior to performance of any study related procedure including screening procedure.
Who cannot join
- Recipient of multiple organ transplantation or scheduled for multiple organ transplantation
- Recipient with a donor-specific anti-HLA antibody or positive cross-match requiring deviation from standard immunosuppressive therapy
- Hepatitis C antibody positive, Hepatitis B antigen positive, or Hepatitis B core antibody positive
- Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrollment into this study
- Concurrent sepsis or active bacterial infection
- In the opinion of the investigator is anatomically a high-risk renal transplant with higher chance for thrombosis or bleeding
Show all 11Show fewer
- Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been treated
- Women of child bearing potential who are breastfeeding
- History of HIV infection
- Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
- Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject's nephrologist.
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Methodist Hospital System
Houston, Texas, 77030
About this study
Official title: A Double-blind, Randomized, Controlled Dose Escalation Trial of Autologuous Mesenchymal Stromal Cells in Living Donor Kidney Transplant Recipients
Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Transplant recipients receive induction therapy and immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent the immune system from attacking the transplanted kidney. This research study will evaluate the safety and activity of mesenchymal stromal stem cells (MSCs) infusion compared to saline-only infusion in reducing the immune suppression necessary to achieve optimal renal function in renal transplant recipients. All participants will receive routine care: basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids.
Read the detailed description
The study is a double-blind, randomized, controlled, dose-escalation and safety study of the investigational product, autologous MSCs, to be assessed for inducing immune suppression in living donor kidney transplant recipients as compared to saline, the placebo infusion. The investigator will obtain exploratory immune response markers to estimate the effect of autologous MSCs on the T- and B-cell response following living donor kidney transplantation. The usual routine care supportive drugs will be given to all: corticosteroids during induction, the calcineurin inhibitor tacrolimus (Prograf®, Astellas Pharma), and mycophenolate mofetil (Cellcept®, Genentech) for maintenance therapy. All subjects will receive basiliximab (Simulect®, Novartis), a standard drug used to induce immune suppression.
Up to 24 patients will be enrolled at the Houston Methodist Hospital. Safety analyses will be conducted after the first 4 subjects have been enrolled and completed the first 30-90 days posttransplant, with subject 2 enrolled 30 days after subject 1 and subject 3 enrolled 30 days after subject 2 (eg, a 30-day window between subject enrollment days). If no safety signal has been detected, the next group of 4 subjects will be enrolled using no less than a 2-week enrollment window from subject 5, 2 weeks from subject 6, and so on. Subjects will be evaluated in the same manner until 8 subjects in the final dosing group have completed 90 days or a decision to stop the study has occurred, whichever comes first. Each subsequent dosing group will begin with a 30-day window of evaluation between subjects enrolled for the first 4 subjects enrolled in the group. If no adverse safety signal has been detected in the first 4 cases in that dosing group, the next 4 subjects enrolled will have a 2-week evaluation window between enrollments. This early evaluation approach will allow for the assessment of the inflammatory period occurring after transplantation. A final safety review will occur at the end of the study and a report will be written.
The study will provide information needed to select a MSC dose level to be used in subsequent clinical trials and to inform the design of subsequent trials.
- Conditions
- Renal Transplantation, Mesenchymal Stem Cells
- Being tested
- Mesenchymal Stromal Stem Cells (MSCs) Infusion, Normal Saline (Placebo) Infusion
- Keywords
- kidney transplantation, graft rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal Stem Cells (MSCs) InfusionBiological
Also called Investigational autologous biological product
Investigational infusion bag containing autologous mesenchymal stromal cells wrapped to cover contents to maintain the blind.
Mesenchymal Stromal Stem Cells Infusion.
Normal Saline (Placebo) InfusionOther
Also called Matching placebo infusion bag
Matching infusion containing normal saline wrapped to cover contents to maintain the blind.
Normal Saline (Placebo) Infusion.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stromal Stem Cells Infusion | Experimental | Intervention: Mesenchymal stromal stem cells infusion. This is the active investigational intervention, administered intravenously at surgery and day 4 post-transplant in a dose-escalation fashion beginning as 1x10^6 cells for the first dose group, 2x10^6 cells for the second dose group, or 3x10^6 cells for the last dose group. The infusion set-up will be covered to mask the group assignment.
Participants will also receive BASILIXIMAB (Simulect, for all subjects at a standard dose, 20mg reconstituted with normal saline or 5% dextrose) on the day of surgery and day 3 or 4 post-transplant administered by a member of the anesthesia team; TACROLIMUS (Prograf for maintenance therapy), MYCOPHENOLATE MOFETIL (Cellcept for maintenance therapy), and CORTICOSTEROIDS as routine care. Receives: Biological: Mesenchymal Stromal Stem Cells (MSCs) Infusion |
| Placebo Infusion | Placebo comparator | Placebo: A normal saline infusion. This is the placebo intervention to occur at surgery and day 4 post-transplant. The infusion set-up will be covered to mask the group assignment. Participants will also receive BASILIXIMAB (Simulect, for all subjects at a standard dose, 20mg reconstituted with normal saline or 5% dextrose) on the day of surgery and day 3 or 4 post-transplant administered by a member of the anesthesia team; TACROLIMUS (Prograf for maintenance therapy), MYCOPHENOLATE MOFETIL (Cellcept for maintenance therapy), and CORTICOSTEROIDS as routine care. Receives: Other: Normal Saline (Placebo) Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants without any infusional toxicity, occurring within 24 hours of infusion.
Infusional toxicity will be assessed as the occurrence of either 1) two or more participants having deep vein thrombosis (Grade 2 thrombotic event); 2) any participant having evidence of the first-pass phenomenon of cells trapping in the lung as evidenced by (a) shortness of breath at rest, (b) requiring ventilator support, or (c) pulmonary edema with hypoxia requiring support; or 3) Grade 4 hypertension or hypotension; or 4) acute myocardial infarction; or 5) new onset congestive heart failure; or 6) capillary leak syndrome; or 7) acute kidney injury; or 8) biopsy-proven rejection.
Measured: 24 hours from end of infusion
Secondary outcomes (1)
Number of participants without any acute rejection, graft loss, or death at 6 months post transplant.
Rejection will be determined as biopsy-proven allograft rejection (BPAR). Graft loss will be counted when the patient loses kidney function to the point that they require chronic renal replacement therapy (e.g., dialysis for more than 8 weeks or a re-transplant).
Measured: 6 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study startDec 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, Ahmed Osama Gaber, MD, The Methodist Hospital Research Institute
- Investigators
- Ahmed O Gaber, MD, Principal investigator, Houston Methodist Physicians Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478215
- Sponsor's protocol ID
- Pro00012858
- Other IDs
- U1111-1169-2289
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2016
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled Dose Escalation Trial of Autologuous Mesenchymal Stromal Cells in Living Donor Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03478215
- Acronym / sponsor ID
- Pro00012858
- Conditions
- Renal Transplantation, Mesenchymal Stem Cells
- Keywords
- kidney transplantation, graft rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 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.
Kidney transplantation is a good treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Transplant recipients receive induction therapy and immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent the immune system from attacking the transplanted kidney. This research study will evaluate the safety and activity of mesenchymal stromal stem cells (MSCs) infusion compared to saline-only infusion in reducing the immune suppression necessary to achieve optimal renal function in renal transplant recipients. All participants will receive routine care: basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids.
Detailed description
The study is a double-blind, randomized, controlled, dose-escalation and safety study of the investigational product, autologous MSCs, to be assessed for inducing immune suppression in living donor kidney transplant recipients as compared to saline, the placebo infusion. The investigator will obtain exploratory immune response markers to estimate the effect of autologous MSCs on the T- and B-cell response following living donor kidney transplantation. The usual routine care supportive drugs will be given to all: corticosteroids during induction, the calcineurin inhibitor tacrolimus (Prograf®, Astellas Pharma), and mycophenolate mofetil (Cellcept®, Genentech) for maintenance therapy. All subjects will receive basiliximab (Simulect®, Novartis), a standard drug used to induce immune suppression.
Up to 24 patients will be enrolled at the Houston Methodist Hospital. Safety analyses will be conducted after the first 4 subjects have been enrolled and completed the first 30-90 days posttransplant, with subject 2 enrolled 30 days after subject 1 and subject 3 enrolled 30 days after subject 2 (eg, a 30-day window between subject enrollment days). If no safety signal has been detected, the next group of 4 subjects will be enrolled using no less than a 2-week enrollment window from subject 5, 2 weeks from subject 6, and so on. Subjects will be evaluated in the same manner until 8 subjects in the final dosing group have completed 90 days or a decision to stop the study has occurred, whichever comes first. Each subsequent dosing group will begin with a 30-day window of evaluation between subjects enrolled for the first 4 subjects enrolled in the group. If no adverse safety signal has been detected in the first 4 cases in that dosing group, the next 4 subjects enrolled will have a 2-week evaluation window between enrollments. This early evaluation approach will allow for the assessment of the inflammatory period occurring after transplantation. A final safety review will occur at the end of the study and a report will be written.
The study will provide information needed to select a MSC dose level to be used in subsequent clinical trials and to inform the design of subsequent trials.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stromal Stem Cells Infusion | Experimental | Biological: Mesenchymal Stromal Stem Cells (MSCs) InfusionIntervention: Mesenchymal stromal stem cells infusion. This is the active investigational intervention, administered intravenously at surgery and day 4 post-transplant in a dose-escalation fashion beginning as 1x10^6 cells for the first dose group, 2x10^6 cells for the second dose group, or 3x10^6 cells for the last dose group. The infusion set-up will be covered to mask the group assignment. Participants will also receive BASILIXIMAB (Simulect, for all subjects at a standard dose, 20mg reconstituted with normal saline or 5% dextrose) on the day of surgery and day 3 or 4 post-transplant administered by a member of the anesthesia team; TACROLIMUS (Prograf for maintenance therapy), MYCOPHENOLATE MOFETIL (Cellcept for maintenance therapy), and CORTICOSTEROIDS as routine care. |
| Placebo Infusion | Placebo comparator | Other: Normal Saline (Placebo) InfusionPlacebo: A normal saline infusion. This is the placebo intervention to occur at surgery and day 4 post-transplant. The infusion set-up will be covered to mask the group assignment. Participants will also receive BASILIXIMAB (Simulect, for all subjects at a standard dose, 20mg reconstituted with normal saline or 5% dextrose) on the day of surgery and day 3 or 4 post-transplant administered by a member of the anesthesia team; TACROLIMUS (Prograf for maintenance therapy), MYCOPHENOLATE MOFETIL (Cellcept for maintenance therapy), and CORTICOSTEROIDS as routine care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females from 18 to 65 years of age
- Planned to receive a primary kidney transplant from a living donor
- Low immunologic risk defined as
- Low risk for thrombotic events and normal prothrombin time, international normalized ratio (INR) and partial thromboplastin time
- Women of child bearing potential have a negative serum pregnancy test prior to transplantation
Key exclusion criteria (11 listed)
- Recipient of multiple organ transplantation or scheduled for multiple organ transplantation
- Recipient with a donor-specific anti-HLA antibody or positive cross-match requiring deviation from standard immunosuppressive therapy
- Hepatitis C antibody positive, Hepatitis B antigen positive, or Hepatitis B core antibody positive
- Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrollment into this study
- Concurrent sepsis or active bacterial infection
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 Stromal Stem Cells (MSCs) InfusionAlso: Investigational autologous biological productInvestigational infusion bag containing autologous mesenchymal stromal cells wrapped to cover contents to maintain the blind. Mesenchymal Stromal Stem Cells Infusion. | Biological | Mesenchymal Stromal Stem Cells Infusion |
| Normal Saline (Placebo) InfusionAlso: Matching placebo infusion bagMatching infusion containing normal saline wrapped to cover contents to maintain the blind. Normal Saline (Placebo) Infusion. | Other | Placebo Infusion |
Primary outcome
Number of participants without any infusional toxicity, occurring within 24 hours of infusion.
Time frame: 24 hours from end of infusion
Infusional toxicity will be assessed as the occurrence of either 1) two or more participants having deep vein thrombosis (Grade 2 thrombotic event); 2) any participant having evidence of the first-pass phenomenon of cells trapping in the lung as evidenced by (a) shortness of breath at rest, (b) requiring ventilator support, or (c) pulmonary edema with hypoxia requiring support; or 3) Grade 4 hypertension or hypotension; or 4) acute myocardial infarction; or 5) new onset congestive heart failure; or 6) capillary leak syndrome; or 7) acute kidney injury; or 8) biopsy-proven rejection.
1 secondary outcome
Number of participants without any acute rejection, graft loss, or death at 6 months post transplant.
Time frame: 6 months post transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Ahmed O Gaber, MD principal investigator
Houston Methodist Physicians Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal Stromal Stem Cells (MSCs) Infusion in people with Renal Transplantation and Mesenchymal Stem Cells, run by The Methodist Hospital Research Institute at 1 site in United States.
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 10 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants without any infusional toxicity, occurring within 24 hours of infusion. (time frame: 24 hours from end of infusion). 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 14 Mar 2025.