|Ref||Diagnosis Number of Cases – Age (Duration of T2DM)||Follow up||Source -SC Type – Passage, dose, Route, Repeat, Interval||Other T2DM Related Therapy||T2DM Related Outcome|
56 (T), 62 (C)
18-60 y (T=8.6 ± 6.5, C=7.3 ± 6.3)
|1-2-3 mo, every 3 mo until -36 mo||T: Auto BM-MNC Dose ? DPA, 1x
C: ( – )
|T: D, E, PST, BGM-MA
C: D, E, PST, IIT, BGM-MA
|HbA1c and C peptide in treatment were significantly better than either pre-therapy values or control.
18/56 patients insulin was discontinued;
19/56 insulin reduction > 50%, 10/56 insulin reduction 15-50%, 9/56 –non responder
In control: 40/62 patients – insulin requirement increased > 50%, 22/62 patients – increased 15-45%.
20 (MNC-HBO), 20 (MNC), 20 (C1=HBO), 20 (C2)
40-65 y (2 – 15 y)
|3-6-9-12 mo||Auto BM-MNC
T1: MNC-HBO= 3641.2 ± 1585.4 M
T2: MNC= 4012.5 ± 1431.9M
DPA – 10 minutes 1x
|T and C: D, L, PST, SBGM- IA||Insulin dose reduction at 12 mo in T1 and T2, C1, C2 – unchanged
Insulin free: T1: 1/20, T2: 2/20
Improvement at 12 mo in AUC C-Pep of T1= T2 > C1, and AUC Ins of T1 and T2.
HbA1c at 3, 6, 9 and 12 mo -reduced significantly both in T1 and T2, but stable in C1 and C2.
FBG at 6, 9 and 12 months – T1 and T2 -reduced Fasting C peptide at 3, 6, 9 and 12 mo significantly elevated in T1 and T2, but remained stable in C1 and C2
11 (T), 10 (C)
T=46.5–56 y (10-15.5 y)
C= 52.5–56 y (16-21 y)
|2-4-6-8-10- 12wk-4-5-6- 9-12 mo||T: auto BM- MNC – 290 M (220 -380 M)
C: sham, saline SP/DA -1x after 12 wk:
PB- GCSF- leucopheresis MNC – 490 (290–730M)
C: sham, saline –IV-1x
|T and C: D, L, E, W-SBGM – IA||12 mo: 50% Insulin reduction
-Tr: 9/11 = 82%, -C:0/10, p= 0.002
Insulin red Tr > C (p=0.001, 6 mo), (p=0.004, 12 mo)
HbA1C maintenance (
<7%): Tr 10/11 (91%), C 6/10 (60%), p= 0.167
Increase in glucagon stimulated C peptide: Tr > C, p= 0.036
10 (MSC), 10 (MNC), 10 (C)
MSC= 36-58 (8-23) MNC= 39.5-50 (8.5-15) C= 43-59 (9-15)
|2-4-8-12- wk-6-9-12 mo||AutoBM-MSC-P4-5 – 1M/ kg BW
Auto BM-MNC – 1B/patient C= vit. B complex SPDA – 1x
|T and C: L, PST,D-SBGM- IA||6/10 (MSC), 6/10 (MNC), 0/10 (C) achieved primary end point: 50% insulin requirement reduction, while maintaining HbA1c
<7.0% -> significant difference
31 (T), 30(C) 18-60 y
|36 mo||T: Wharton jelly MSC P4
IV – 2x (interval 4 wk)
|T and C: D, E, PST, SBGM- MA||Blood glucose, HbA1c, Cpeptide, homeostasis model assessment of pancreatic islet cell function signifi- cantly improved- compared to control.
Incidence of diabetic complications: Tr – no increase vs baseline, C: 4/30- new diabetic retinopathy, 3/30 new diabetic neuropathy 3/30 new diabetic nephropathy –> statistically significant difference (Tr vs C, P= 0.007)
Insulin dose reduction:
Tr: 18/31- 50% insulin dose reduction ( where 10/31 – insulin free from 311 mo postWJMSC, and insulin free duration 12.5±6.8 months),5/31 -1550% reduction, and
8/31 non responder
Control: 14/30: >50% insulin dose increase, 16/30: 1545% insulin dose increase – 30/30 – non responder
|25||T2DM + impotence2 7 (T), 3 (C)
57-87 (12-52 y, impo- tence minimal 6 months)
|2wk – 11 mo||T: UCB SC -His tos- tem, ABO, HLA- ABC, DR, and sex- matched – 15M
C: saline Injection – CC -1x
|T and C:PST, D-SBGM-MA||Tr: Blood glucose levels decreased by 2 weeks, and medication dosages were reduced for 4 to 7 months (6/7). HbA1c levels improved after treatment for up to 3 to 4 months (7/7)
Reduced insulin dose after 1 month (2/7)
Control: no improvement in blood glucose level, HbA1c, and insulin dose.
15 (T1), 15 (T2), 15 (T3), 3×5 C)
T1= 57.7±8.2y (10.8± 7.3y )
T2= 55.3±11.4y (10.2± 5.7y)
T3= 57.2 ±6.6y (9.6±4.5y)
C= 58.7 ±7.3y (9.8±6.7y)
2y post study
|MPC- P(?) Rexleme- strocel-L – mesoblas Inc, cryo-thawed
T1=0.3 M/kg T2=1 M/kg T3=2 M/kg C= placebo IV- 45 minutes 1X
|T and C: L, PST, BGM-RT||Tr: HbA1c – reduced – at all time points after week 1, C: a small increase in HbA1c
Clinical target HbA1c
<7% was achieved by 0/15 of Control, 2/15 of T1, 1/15 of T2, and 5/15 of T3 (P < 0.05) Glycemic rescue therapy was required by: 1/15 of Con- trol, 2/15 of T1, 0/15 of T2, 1/15 of T3
13 (T), 13 (C) 10-58 y (0.5 – 11 y)
|1y||Hu fetal liver HSC – 35-55 M (20% CD34)- cryo-thawed
Saline (C) IV – 1x
|T and C: BGM-FU||Up to 1 y, no significant improvement in fasting blood glucose, and C peptide compared to control.
Improvement in – HbA1c only at 6th mo: 7.9±1.3 in treatment vs 7.0 ± 0.86 in control (p=0.046).
None of the treatment become insulin free
Ref= reference number, T2DM= Type 2 diabetes mellitus, treatment control allocation: 1 patient option, 2 successive: 2 Treatment – 1 Control, others: random, 3single blind multi center (18 –USA), 4=T2DM and T1DM, T= treatment, C= control, y= year(s), MNC= mononuclear cell, HBO= hyperbaric oxygen, MSC= mesenchymal stem cell, mo= month(s), wk= week(s)
SC= stem cell, Auto= autologous, BM= bone marrow, ?= data not available, DPA= dorsal pancreatic artery/substitute, M= million, SP/DA= superior pancreatic or duodenal artery, PB= peripheral blood, GCSF= granulocyte colony stimulating factor, IV- intra venous, P= passage, BW= body weight, B= billion, vit.= vitamin, SPDA= superior pancreaticoduode- nal artery, UCB= umbilical cord blood, CC= corpora cavernosa (penile root clamped with a band 30 min), MPC= mesenchymal progenitor cell, cryo= cryopreserved, hu= human, HSC= haematopoeitic stem cell, cryo= cryopreserved,D= diet, E= exercise, PST= previous standard therapy, BGM = blood glucose monitoring, MA= medication adjustment, IIT= insulin intensification therapy, L= lifestyle, SGBM= self blood glucose monitoring, IA= insulin adjustment, W-SGBM= weekly SGBM, D-SGBM= daily SGBM (minimum 5 points/week), RT= rescue therapy using oral anti diabetic agent, except thiazolidinediones in case there was unacceptable hyperglycemia, FU= at follow up
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