Abstract
Background aims
To explore the long-term safety and benefit of umbilical cord mesenchymal stromal
cell (MSCs) plus autologous bone marrow mononuclear cell (aBM-MNC) stem cell transplantation
(SCT) without immunotherapy in established type 1 diabetes (T1D).
Methods
In the primary completion of this trial (ClinicalTrials.gov identifier: NCT01374854),
the authors randomized patients (n = 21 per group) to either SCT or standard care
(control) and previously reported effects on insulin secretion. The authors report
about the incidence of chronic diabetes complications (primary endpoint) after 8 years
of follow-up. The authors also report on secondary endpoints, safety, islet function
and metabolic control.
Results
Data were obtained from 14 of 21 patients in the SCT group and 15 of 21 patients in
the control group who completed follow-up. At 8 years, the incidence of peripheral
neuropathy was 7.1% (one of 14) in the SCT group versus 46.7% (seven of 15) in the
control group (P = 0.017). The incidence of diabetic nephropathy was 7.1% (one of 14) in the SCT group
versus 40.0% (six of 15) in the control group (P = 0.039). The incidence of retinopathy was 7.1% (one of 14) in the SCT group versus
33.3% (five of 15) in the control group (P = 0.081). Two patients (two of 14, 14.3%) in the SCT group and 11 patients (11 of
15, 73.3%) in the control group developed at least one complication (P = 0.001). One and six patients in the SCT group and control group, respectively,
had at least two complications (P = 0.039). No malignancies were reported in the treated group.
Conclusions
Co-transplantation of umbilical cord MSCs and aBM-MNCs in patients with established
T1D was associated with reduced incidence of chronic diabetes complications.
Key Words
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Article info
Publication history
Published online: January 25, 2022
Accepted:
September 18,
2021
Received:
May 30,
2021
Identification
Copyright
© 2022 Published by Elsevier Inc. on behalf of International Society for Cell & Gene Therapy.
