Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose for Diabetes Mellitus, Type 2

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Rochester, Rochester, MN
Diabetes Mellitus, Type 2+11 More
Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose - Biological
Eligibility
18+
All Sexes
Eligible conditions
Diabetes Mellitus, Type 2

Study Summary

This study is evaluating whether stem cells from fat may help treat kidney disease.

See full description

Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Chronic Kidney Diseases
  • Kidney Failure
  • Diabetic Nephropathies
  • Diabetes Mellitus
  • Diabetes, Autoimmune
  • Kidney Diseases
  • Renal Insufficiency, Chronic
  • Chronic Kidney Disease (CKD)
  • Renal Insufficiency
  • Diabetic Kidney Disease (DKD)
  • Diabetes Mellitus, Type 1
  • Type 2 Diabetic Nephropathy
  • Impaired Renal Function

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose will improve 1 primary outcome and 1 secondary outcome in patients with Diabetes Mellitus, Type 2. Measurement will happen over the course of pretreatment, month 12.

Baseline through Month 15
Adverse Events
pretreatment, month 12
Kidney Function

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
Higher Dose MSC

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Autologous Adipose-derived Mesenchymal Stem/stromal Cells (MSC) Higher Dose is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Higher Dose MSC
Biological
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Higher Dose
Lower Dose MSC
Biological
This arm will receive autologous adipose-derived Mesenchymal stem/stromal cells (MSC) Lower Dose.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through month 15
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline through month 15 for reporting.

Who is running the study

Principal Investigator
L. J. H.
LaTonya J. Hickson, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diabetes mellitus (on anti-diabetes drug therapy)
Age 45-75 years
eGFR 25-55 ml/min/1.73m2 at time of consent with: a) eGFR decline of 5 ml/min over 18 months or 10 ml/min over 3 years or b) an intermediate or high 5-year risk of progression to end-stage kidney failure (dialysis or transplant) based on the validated Tangri 4-variable (age, sex, eGFR, urinary albumin-creatinine ratio) kidney failure risk equation https://kidneyfailurerisk.com/
Primary cause of kidney disease is diabetes without suspicion of concomitant kidney disease beyond hypertension
Spot urine albumin:creatinine ≥30 mg/g unless on RAAS inhibition
Ability to give informed consent

Patient Q&A Section

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

What are the signs of diabetes mellitus, type 2?

Add answer

Type 2 diabetes is marked by complications of long duration. As many as 40% of patients may be asymptomatic for 20 or more years, thus delaying the diagnosis and compromising treatment options. The absence of clinically obvious symptoms is one of the key components of its diagnosis.

Unverified Answer

What are common treatments for diabetes mellitus, type 2?

Add answer

The treatment of diabetes tends to be based on the current paradigm and has a long history. The treatment for diabetes typically includes dietary modifications, lifestyle modification, lifestyle changes such as exercise, and prescription medications. Some specific medications used for diabetes treatment include glyburide and metformin. Other medications, such as acarbose, are used for specific patient needs. There are no medicines that can cure diabetes.

Unverified Answer

What causes diabetes mellitus, type 2?

Add answer

The prevalence rates of T2DM in different Asian ethnicities are varying, but were generally similar in a group of Asian patients from the Netherlands. The T2DM is more frequent in the male sex. Although T2DM tends to affect individuals younger than 40 years, the age at the onset of the disease in this study cohort was not significantly different between male and female. However, diabetic patients younger than 40 tend to receive poorer glycemic control by their diabetic physicians than those aged 40 years or older. Diabetic patients of either sex should gain special attention to early diabetic screening and early diagnosis of diabetic micro- and macrovascular complications.

Unverified Answer

How many people get diabetes mellitus, type 2 a year in the United States?

Add answer

About 14 million people have been diagnosed with DM type 2 at some point in their lives or are pre-diabetic in the USA annually. The age-adjusted prevalence of diagnosed diabetes is 16% among whites, 3% among blacks and 20% among Hispanics. DM type 2 prevalence varies by sex, ethnicity and socioeconomic factors. The disparity of DM type 2 between sexes and ethnic groups may reflect different environmental and genetic exposures.

Unverified Answer

Can diabetes mellitus, type 2 be cured?

Add answer

Diabetic patients who are carefully managed with close blood pressure monitoring and with an intensive glycemic control regimen can live long healthy lives, and diabetic patients can be cured, if proper management is implemented. Such a comprehensive strategy is the only proven cure for long-standing, well-controlled T2DM.

Unverified Answer

What is diabetes mellitus, type 2?

Add answer

Diabetes mellitus is a disease of high prevalence and many ramifications. The consequences can be seen in all aspects of the life. The health related consequences of untreated diabetes can be debilitating. Diabetes, as the disease, affects over 20 million people in the U.S. alone and is still on the rise.

Unverified Answer

Is autologous adipose-derived mesenchymal stem/stromal cells (msc) higher dose typically used in combination with any other treatments?

Add answer

Findings from a recent study supports the use of a high dose of autologous adipose derived MSC treatment in combination with any other treatments for wound healing.

Unverified Answer

What does autologous adipose-derived mesenchymal stem/stromal cells (msc) higher dose usually treat?

Add answer

The present data indicate that higher dose autologous MSC are more effective in improvement of glycometabolic status, adiposity and insulin sensitivity after high fat/high fructose diet-induced metabolic disturbances in Wistar normoglucidaemic rats. The present data suggest that the higher dose of autologous MSC might be considered as a good therapy option for non-insulin dependent diabetes mellitus.

Unverified Answer

Does diabetes mellitus, type 2 run in families?

Add answer

Diabetes-prone families show a strong degree of clustering at the grandparent and great-grandparent level, although the underlying genetic relationship between diabetes-prone persons and their relatives is not well understood.

Unverified Answer

What is the average age someone gets diabetes mellitus, type 2?

Add answer

Approximately 11% of respondents reported the average age at DM2 onset. Results from a recent paper show that diabetes is a rising concern for both children and adults of every age.

Unverified Answer

Who should consider clinical trials for diabetes mellitus, type 2?

Add answer

A systematic approach to the identification of patients should be employed. This approach should be based at least on age and DM2 risk factors. Additional risk factors can be taken into account, for example diabetes autoantibodies. It is the responsibility of the clinician to define and tailor the therapeutic choices for each individual.

Unverified Answer

What is the latest research for diabetes mellitus, type 2?

Add answer

Type 2 diabetes mellitus is a disease with different causes and a variable pathogenesis, and is characterized by several risk factors, but not a single one (e.g. diabetes is not caused by an increase in a single blood sugar level). Although our knowledge has increased over the past decades, it is far from being completely understood, and the number of available therapeutic options are still rather limited.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Diabetes Mellitus, Type 2 by sharing your contact details with the study coordinator.