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MSC Therapy for Chronic Kidney Disease
Study Summary
This trial is testing if it is safe to give patients with kidney disease stem cells through IV. There are two groups getting different doses at different times.
- Chronic Kidney Disease
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your hemoglobin level is less than 9 grams per deciliter.You weigh more than 150 kilograms or your BMI is over 50.You had a serious heart problem or uncontrolled irregular heartbeats in the last 6 months.You have had liver cirrhosis in the past.You had COVID-19 in the past 3 months.You have had hepatitis B or C, or HIV, and it has not been cured.You have had an allergic reaction to blood transfusions or platelets in the past.You are currently smoking or using tobacco products.You use illegal drugs or drink too much alcohol.You have a high level of protein in your urine, more than 5 grams per day.You need kidney treatment like dialysis or a kidney transplant.You have had a solid organ transplant in the past.If your kidney function is a little low, and you have high levels of protein in your urine despite taking the highest dose of certain kidney medications, you may not be able to participate.If your kidney function is between 25-44 ml/min/1.73m2, you must have high levels of protein in your urine even after taking the highest tolerated dose of certain medications for your kidneys.Your average blood sugar level (Hemoglobin A1c) is less than or equal to 8% even with the highest dose of your diabetes medication.You are currently taking medication that weakens your immune system.You must be between 30 and 80 years old.Your kidney function, measured by eGFR, is between 25 and 55 ml/min/1.73m2.You have a history of long-term low blood pressure with a systolic blood pressure consistently below 85 mmHg.You have a history of blood clotting disorders such as pulmonary embolism or deep venous thrombosis.Your blood pressure is consistently high, even with maximum doses of at least 2 different types of blood pressure medications.You have certain kidney diseases that are currently causing problems, like ANCA-associated glomerulonephritis or lupus nephritis.You have a specific genetic condition called polycystic kidney disease.You have had a kidney transplant in the past.You have chronic obstructive pulmonary disease or asthma that needs daily medication.You currently have cancer.You have a current infection, like pneumonia or osteomyelitis.You have a kidney condition called glomerulonephritis that is not under control, or you have very high levels of protein in your urine.You have a kidney condition with a lot of protein in your urine, low levels of albumin in your blood, and swelling.
- Group 1: Dose Arm 1
- Group 2: Dose Arm 2
- 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
Who is eligible to be part of this clinical experiment?
"This experiment is welcoming 20 individuals suffering from CKD aged between 30 and 80. The following criteria must be met by potential participants: Age range of 30-80 years, eGFR 25-55 ml/min/1.73m2 with an albumin:creatinine ratio ≥300 mg/g or urine proteinuria ≥300 mg/day despite RAAS drug therapy (e.g., ACE inhibitors, Angiotensin receptor blockers), for eGFR levels of 25-44ml/min/1.73m2 a minimum A:C ratio of≥30mg / g is needed even when on"
Is the age limitation of this trial confined to those under 35 years old?
"The scope of the trial is limited to adults aged between 30 and 80 years old."
What risks are associated with Allogeneic adipose-derived mesenchymal stem cells (MSC) usage?
"Since this is a Phase 1 trial and only limited evidence of safety and efficacy exists, our team at Power rated the security of Allogeneic adipose-derived mesenchymal stem cells (MSCs) as a 1 on their scale."
What is the current participant capacity for this medical trial?
"Affirmative. Data hosted on clinicaltrials.gov discloses that this research, which was initially posted on July 1st 2022, is actively recruiting subjects. Approximately 20 people are required to be gathered from 2 separate medical sites."
Has registration for this trial opened yet?
"Affirmative. Clinicaltrials.gov displays that the trial, which was initial posted on July 1st 2022, is actively seeking applicants. In total 20 patients are required to enroll at 2 sites."
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