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MSCs Infusion for Kidney Transplant

Phase 2

Waitlist Available

Led By Ahmed O Gaber, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post transplant

Awards & highlights

Study Summary

This trial will test whether mesenchymal stromal stem cells can reduce the amount of immunosuppression necessary to achieve optimal renal function in kidney transplant recipients.

Eligible Conditions

Kidney Transplant
Mesenchymal Stem Cells

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants without any infusional toxicity, occurring within 24 hours of infusion.

Secondary outcome measures

Number of participants without any acute rejection, graft loss, or death at 6 months post transplant.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mesenchymal Stromal Stem Cells InfusionExperimental Treatment1 Intervention

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.

Group II: Placebo InfusionPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

271 Previous Clinical Trials

80,351 Total Patients Enrolled

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,793 Total Patients Enrolled

Ahmed O Gaber, MDPrincipal InvestigatorHouston Methodist Physicians Organization

2 Previous Clinical Trials

200 Total Patients Enrolled

Media Library

Mesenchymal Stromal Stem Cells (MSCs) Infusion Clinical Trial Eligibility Overview. Trial Name: NCT03478215 — Phase 2

Kidney Transplant Research Study Groups: Mesenchymal Stromal Stem Cells Infusion, Placebo Infusion

Kidney Transplant Clinical Trial 2023: Mesenchymal Stromal Stem Cells (MSCs) Infusion Highlights & Side Effects. Trial Name: NCT03478215 — Phase 2

Mesenchymal Stromal Stem Cells (MSCs) Infusion 2023 Treatment Timeline for Medical Study. Trial Name: NCT03478215 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric inclusion a factor in the recruitment of participants for this trial?

"According to the prerequisites for this research program, participants must be at least 18 and not older than 65."

Answered by AI

Is participation in this trial open to me?

"To qualify for this study, applicants must possess functioning kidneys and be within the 18-65 year old age range. Approximately 24 participants are needed to complete the trial."

Answered by AI

How many participants is this medical trial currently accommodating?

"Affirmative. On clinicaltrials.gov, the current status of this research study is recruiting participants with a post-date and edit date of December 1st 2016 and March 8th 2022 respectively. To complete their experiment, 24 individuals need to be recruited from one medical facility."

Answered by AI

How can patients mitigate risk when receiving an infusion of Mesenchymal Stromal Cells?

"Given its Phase 2 status, our team at Power judged MSCs Infusion to be a safety rating of two. While there is evidence that this intervention won't cause harm, efficacy data remains unconfirmed."

Answered by AI

Does this research endeavor currently accept new participants?

"Indeed, the information on clinicaltrials.gov indicates that this medical trial is actively enrolling patients. The initial post date of this study was December 1st 2016 and it has been updated as recently as March 8th 2022. 24 individuals are needed from a single centre for this research project to be completed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

Ahmed Osama Gaber, MD 2016. "Mesenchymal Stromal Cells in Living Donor Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03478215.

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