Renal Autologous Cell Therapy (REACT) for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Boise Kidney and Hypertension Institute - Frenova, Nampa, ID
Type 2 Diabetes Mellitus+7 More
Renal Autologous Cell Therapy (REACT) - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a second REACT injection can be given to the same kidney.

See full description

Eligible Conditions

  • Type 2 Diabetes Mellitus
  • Type 1 Diabetes Mellitus
  • Chronic Kidney Disease (CKD)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Renal Autologous Cell Therapy (REACT) will improve 2 primary outcomes and 25 secondary outcomes in patients with Type 2 Diabetes Mellitus. Measurement will happen over the course of From baseline thru week 34.

Month 34
Changes from Baseline in serial measurements of UACR
Changes from Baseline in serial measurements of blood urea nitrogen
Changes from Baseline in serial measurements of cystatin C
Changes from Baseline in serial measurements of hematocrit
Changes from Baseline in serial measurements of hemoglobin
Changes from Baseline in serial measurements of phosphorus
Changes from Baseline in serial measurements of serum creatinine (sCr)
Changes from Baseline in serial measurements of urine albumin
Changes from Baseline in serial measurements of urine creatinine
Time to increase of greater than or equal to 30% and of at least 30 mg/g in urine albumin/creatinine ratio (UACR)
Week 34
Time to eGFR less than 15 mL/min/1.73m²
Time to reduction of greater than or equal to 40% in eGFR
Month 24
Estimated glomerular filtration rates
Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 24 months after the last REACT injection.
Screening thru month 34
Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) over 24 months
Thru month 34
Time to earliest of specified eGFR, increase of UACR or all-cause mortality
Time to renal death
Thru week 34
Event of procedural death
Reduction in concomitant medication related to hypertension and glycemic control.
Time to cardiovascular death
Time to first episode or intensification of anemia therapy.
Time to first episode or intensification of anti-hypertensive therapy.
Time to first episode or intensification of bone and mineral dysmetabolism therapy.
Time to first episode or intensification of dyslipidemia therapy.
Time to first episode or intensification of hyperkalemia therapy.
Time to first episode or intensification of metabolic acidosis therapy.
Time to first episode or intensification of sodium and water restriction therapy.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

5 Treatment Groups

1 REACT Injections
1 of 5
1 REACT® Injection
1 of 5
1 REACT Injection
1 of 5
2 REACT® injections
1 of 5
2 REACT injections
1 of 5
Experimental Treatment

This trial requires 50 total participants across 5 different treatment groups

This trial involves 5 different treatments. Renal Autologous Cell Therapy (REACT) is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

1 REACT Injections
Biological
Cohort 2 subjects will receive 1 REACT injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT injection into the contralateral kidney.
1 REACT® Injection
Biological
Cohort 2 subjects will receive 1 REACT® injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT® injection into the contralateral kidney.
1 REACT Injection
Biological
Cohort 2 subjects will receive 1 REACT injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT injection into the contralateral kidney.
2 REACT® injections
Biological
Cohort 1 subjects will receive 2 REACT® injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).
2 REACT injections
Biological
Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: thru month 34
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly thru month 34 for reporting.

Closest Location

Boise Kidney and Hypertension Institute - Frenova - Nampa, ID

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject has a hemoglobin A1C level of less than 10% at the Screening Visit. show original
A person aged 30 to 80 who consents on the date it is signed. show original
The person has diabetes, either type 1 or type 2, which is being controlled according to the usual standards of care. show original
The subject has renal disease due to diabetic nephropathy. show original
The subject has a documented clinical diagnosis of kidney disease, with an estimated GFR between 20 and 50 mL/min/1.73m² inclusive show original

Patient Q&A Section

How many people get kidney diseases a year in the United States?

"Approximately 8 in 10 persons ≥ 40 years old and 1 in 5 persons ≥ 60 years old have some degree of albuminuria compared to the general US population." - Anonymous Online Contributor

Unverified Answer

What causes kidney diseases?

"The causes of kidney diseases include genetic and environmental risk factors such as family history, lifestyle and environmental factors, and drug use. There are no single factors that explain why the disease process happens. It remains an exciting field for research in the 21st century." - Anonymous Online Contributor

Unverified Answer

Can kidney diseases be cured?

"Kidney diseases can seldom be cured. All treatments aim at relieving symptoms rather than curing diseases. But it is possible that some of the treatments listed are effective in the treatment of renal diseases, especially glucosuria and hyperkalemia." - Anonymous Online Contributor

Unverified Answer

What is kidney diseases?

"There exists a wide range of kidney diseases that can be categorised into nine major and several minor group diseases. Their presence, severity and distribution varies widely from person to person and with age and sex." - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney diseases?

"There are a variety of reasons that children may have renal disease. Some of the first signs are vomiting and/or a decrease in growth. Other common signs are pain and a decreased amount of urine output. Renal disease also may result from the child's body not functioning properly. These include problems metabolizing proteins and blood proteins, as well as electrolytes like sodium and potassium. Renal disease can also cause damage to the kidneys, often resulting in shortness of breath. While the signs of kidney disease are similar in children, one must have an eye on the possibility of any rash or itching to check for signs of an autoimmune reaction." - Anonymous Online Contributor

Unverified Answer

What are common treatments for kidney diseases?

"Kidney disease is often treated with drugs that act on the renal tubules and glomeruli to reduce proteinuria and blood pressure. A range of non-pharmaceutical interventions are available to manage renal disease." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating kidney diseases?

"There have been many new methods of treating kidney diseases, but with limited success. Many drugs are in clinical trials or trials in general, and their efficacy should be evaluated by a physician specializing in kidney disease." - Anonymous Online Contributor

Unverified Answer

What is the latest research for kidney diseases?

"Most investigators are interested in more comprehensive knowledge of kidney diseases, and the best knowledge to support an effective prevention. New discoveries in the fields include those that clarify the effects of diet and lifestyle factors and the mechanisms influencing inflammation. It is imperative that clinicians integrate the results into a conceptual framework to better counsel patients and their patients' families about the optimal management of the disease." - Anonymous Online Contributor

Unverified Answer

Is renal autologous cell therapy (react) typically used in combination with any other treatments?

"Despite a relatively small number of studies and trials, the authors identified multiple treatments of renal AC cell therapy, but most of these trials were performed alongside other cell therapies or medication. The authors concluded that more research is needed before further consideration for use in clinical practice can be made." - Anonymous Online Contributor

Unverified Answer

Is renal autologous cell therapy (react) safe for people?

"Renal autologous cell therapy at doses of up to 1 x 106/kg was well tolerated even in elderly persons with advanced renal disease. Treatment did not cause a significant increase in serum creatinine or creatinine clearance. Results from a recent paper indicate that autologous cells administered for chronic kidney maintenance therapy, even in individuals>75 years, can be safely and effectively delivered to this patient population." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in renal autologous cell therapy (react) for therapeutic use?

"These data warrant further studies to see whether the new therapeutic approaches incorporating react cell transfusions will prove efficacious in the treatment of chronic diseases of the kidneys and if possible in other disease states, such as diabetes mellitus." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets kidney diseases?

"Age when getting kidney diseases is generally higher with patients that have more comorbid illnesses and that have been receiving medical care for a longer period of time. The average age of kidney diseases at the age of first diagnosis is around 49.5 years among all the races and around 49 years among whites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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