Table 2 Summary of the major clinical trials utilising MSCs as a treatment for T1D

NCT01068951

N/A

Intravenous, autologous transplantation of MSCs (approximately 2 × 10⁶ cells/kg body weight)

Patients in the control arm showed losses in both C-peptide peak values and C-peptide when calculated as area under the curve during the first year. In MSC-treated patients, these responses were preserved or even increased. No side effects of MSC treatment were observed

Fresh

Completed 2014

[20]

NCT01374854

1/2

1 × 10⁶/kg UC-MSCs are infused through the pancreatic artery along with BM-MNCs by interventional therapy and another same dose of UC-MSCs administered 1 week post-intervention

C-peptide increased 105.7% in 20 of 21 responders versus 7.7% decrease in control subjects. HbA1C decreased 12.6% in treated versus 1.2% increase in control subjects. Daily insulin requirements decreased 29.2% in treated versus no change in control subjects.

Fresh

Completed 2012

[21]

NCT00703599

1/2

i.v. administration of autologous activated stromal vascular fraction derived from 100–120 ml lipoaspirates following mini-liposuction of abdominal adipose tissue

Not reported

Frozen

Estimated completion of 2009

[22]

NCT01219465

1/2

i.v transfusion of UC-MSCs (2 × 10⁷ cells/kg body weight)

No reported acute or chronic side effects in MSC-treated versus saline control. Both HbA1c and C-peptide in MSC-treated patients were significantly better than either pre-therapy values or saline control patients during the follow-up period

Fresh

Completed 2012

[23]

NCT01996228 NCT01350219

1/2

Human UC-MSCs within the Stem Cell Educator device

A single treatment provided lasting reversal of autoimmunity that allowed regeneration of islet β cells and improvement of metabolic control in subjects with long-standing T1D

Fresh

Recruiting

[24–27]

NCT02057211

2

Transfusion of autologous MSC versus sham MSC transfusion vs placebo control

N/A

Fresh

Recruiting

N/A

NCT01143168

1

Multiple transplantation of BM-MNC + UC-MSCs

Not reported

Frozen

Estimated completion of 2011

Cellonis Biotech Pty Ltd.

NCT00646724

1/2

Co-transplantation of islet allograft and MSC autograft

Not reported

Frozen

Estimated completion of 2012

N/A

NCT01322789

1/2

Four consecutive intravenous infusions, 1 week apart, followed by four consecutive infusions 1 month apart

Not reported

Frozen

Estimated completion of 2015

N/A

NCT01496339

1/2

1 × 10⁶/kg MenSCs are infused through the pancreatic artery or intravenously once a week in four consecutive therapies

Not reported

Frozen

Estimated completion of 2014

S-Evans Biosciences Pty Ltd.

NCT02644759

1/2

Transplantation of autologous CD34⁺/CD133⁺ cells into the pancreatic artery and capillaries via interventional radiology techniques. Immunomodulation by incubation of autologous UC-MSCs for 3–6 h, and return of autologous WBCs back via intravenous injection

N/A

Fresh

Ongoing, not recruiting

Stem Cells Arabia

NCT00690066

2

Intravenous infusion of ex vivo cultured adult human MSCs vs placebo intravenous infusion of excipients of PROCHYMAL®

Not reported

Frozen

Completed 2014

Osiris/Mesoblast International Sarl

NCT01157403

2/3

Intravenous autologous transplantation of BMSC (approximately 2.5 × 10⁶ cells/kg body weight)

Not reported

Frozen

Estimated completion of 2014

N/A