MSC and MC in Type 2 Diabetes Mellitus

What Was Tested

This registered phase 1, phase 2 trial tested Insulin (regular human).

Cell injury in human islets induced by non-immune mediated inflammation occur in vitro upon hyperglycemia in type 2 diabetes mellitus.

Infusion of MCs and autologous bone marrow mesenchymal stem cells in combination might exert enhanced repairing effects.

It had three arms (groups): MSC+MC (experimental), MC (active comparator) and Insulin (active comparator).

Infusion of BMMSC+BMMNC and insulin injection.

Infusion of BMMNC and insulin injection.

Insulin injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 22 actual participants took part.

It was open to people of any sex aged from 40 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to provide written informed consent. Mentally stable and able to comply with the procedures of the study protocol. Clinical history compatible with type 2 diabetes (T2DM) as defined by the Expert Committee on the Diagnosis and classification of Diabetes Mellitus. Onset of T2DM disease at ≥ 35 years of age. T2DM duration ≥ 3 and ≤ 20 years at the time of enrollment.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-01 with completion listed for 2013-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: macrovascular complications (time frame: 8 years). microvascular complications (time frame: 8 years).

It also tracked 15 secondary outcomes, for example DPN, MI, angina, stroke, amputation and DN.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin (regular human) in 22 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.