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A-MSC Therapy for Kidney Transplant Rejection
Study Summary
This trial is testing a new treatment for kidney transplant patients. The treatment is an infusion of allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC) directly into the renal artery. The purpose of the trial is to see if the treatment is safe and can help reduce inflammation in the transplanted kidney and treat rejection.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have had high levels of protein in my urine multiple times in the last year.I understand the study and agree to participate.My kidney function is stable, with creatinine levels not much higher than before my biopsy.I have had treatment for urinary blockage after a transplant.I had a kidney transplant and a recent biopsy showed signs of rejection.
- Group 1: High Dose Group
- Group 2: Low Dose Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do you accept individuals aged 35 and over for this trial?
"This clinical trial is open to applicants that are at least 18 years old, yet not beyond the age of 70."
Is there a current opportunity to participate in the experiment?
"Affirmative. Data hosted on clinicaltrials.gov substantiates that this medical experiment, which was initially posted on November 1st 2022, is actively recruiting patients. 12 individuals need to be enlisted from a solitary medical centre."
What criteria must be met in order to qualify for this experimentation?
"This medical trial is recruiting 12 participants with ages between 18 and 70, who have experienced renal transplantation. Additionally, candidates must have the ability to comprehend informed consent documents as well as some defined laboratory values such as serum creatinine levels and estimated eGFRs. Protocol biopsies must be collected within 3 months of enrolment for diagnosis of either ABMR or cellular rejection; microvascular inflammation scores for glomerulitis (g) and peritubular capillaritis (ptc), tubulitis (t) intensity score for interstitial inflammation (i); intimal arteritis score(v). Mixed cases"
Has the FDA sanctioned Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) for public use?
"The safety of Low dose adipose tissue derived mesenchymal stromal cells (A-MSC) is rated at a 1 due to the current Phase 1 trial, which lacks detailed data surrounding its efficacy and safety."
What is the total number of participants in this research endeavor?
"Affirmative. According to the clinicaltrials.gov website, this trial is currently enrolling participants after being initially posted on November 1st 2022 and most recently updated on the 7th of that month. A dozen patients are desired from a single medical site for participation in this experiment."
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