Clinical trial with control: variables related to the outcomes of stem cell therapy.
Ref 20
Diagnosis Number of Cases – Age (Duration of T2DM)
T2DM156 (T), 62 (C)18-60 y (T=8.6 ± 6.5, C=7.3 ± 6.3)
Follow Up
1-2-3 mo, every 3 mo until -36 mo
Source -SC Type – Passage, dose, Route, Repeat, Interval
T: Auto BM-MNC Dose ? DPA, 1xC: ( – )
Other T2DM Related Therapy
T: D, E, PST, BGM-MAC: D, E, PST, IIT, BGM-MA
T2DM Related Outcome
HbA1c and C peptide in treatment were significantly better than either pre-therapy values or control.In Treatment:18/56 patients insulin was discontinued;19/56 insulin reduction > 50%, 10/56 insulin reduction 15-50%, 9/56 –non responderIn control: 40/62 patients – insulin requirement increased > 50%, 22/62 patients – increased 15-45%.
Ref 21
Diagnosis Number of Cases – Age (Duration of T2DM)
T2DM20 (MNC-HBO), 20 (MNC), 20 (C1=HBO), 20 (C2)40-65 y (2 – 15 y)
Follow Up
3-6-9-12 mo
Source -SC Type – Passage, dose, Route, Repeat, Interval
Auto BM-MNCT1: MNC-HBO= 3641.2 ± 1585.4 MT2: MNC= 4012.5 ± 1431.9MDPA – 10 minutes 1x
Other T2DM Related Therapy
T and C: D, L, PST, SBGM- IA
T2DM Related Outcome
Insulin dose reduction at 12 mo in T1 and T2, C1, C2 – unchangedInsulin free: T1: 1/20, T2: 2/20Improvement 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
Ref 22
Diagnosis Number of Cases – Age (Duration of T2DM)
T2DM11 (T), 10 (C)T=46.5–56 y (10-15.5 y)C= 52.5–56 y (16-21 y)
Follow Up
2-4-6-8-10- 12wk-4-5-6- 9-12 mo
Source -SC Type – Passage, dose, Route, Repeat, Interval
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
Other T2DM Related Therapy
T and C: D, L, E, W-SBGM – IA
T2DM Related Outcome
12 mo: 50% Insulin reduction-Tr: 9/11 = 82%, -C:0/10, p= 0.002Insulin 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
Correlation insulin decrease-C peptide increase r= 0.8, p=0.01)
Ref 23
Diagnosis Number of Cases – Age (Duration of T2DM)
T2DM10 (MSC), 10 (MNC), 10 (C)MSC= 36-58 (8-23) MNC= 39.5-50 (8.5-15) C= 43-59 (9-15)
Follow Up
2-4-8-12- wk-6-9-12 mo
Source -SC Type – Passage, dose, Route, Repeat, Interval
AutoBM-MSC-P4-5 – 1M/ kg BWAuto BM-MNC – 1B/patient C= vit. B complex SPDA – 1x
Other T2DM Related Therapy
T and C: L, PST,D-SBGM- IA
T2DM Related Outcome
6/10 (MSC), 6/10 (MNC), 0/10 (C) achieved primary end point: 50% insulin requirement reduction, while maintaining HbA1c
<7.0% -> significant difference
MNC group: Increase in glucagon stimulated C peptide
MSC group: Improvement in insulin sensitivity index and increase in IRS-1 gene expression
Ref 24
Diagnosis Number of Cases – Age (Duration of T2DM)
T2DM31 (T), 30(C) 18-60 y(T=8.93±5.67 C=8.3±6.07)
Follow Up
36 mo
Source -SC Type – Passage, dose, Route, Repeat, Interval
T: Wharton jelly MSC P41M/kg BWC: SalineIV – 2x (interval 4 wk)
Other T2DM Related Therapy
T and C: D, E, PST, SBGM- MA
T2DM Related Outcome
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
Ref 25
Diagnosis Number of Cases – Age (Duration of T2DM)
T2DM + impotence2 7 (T), 3 (C)57-87 (12-52 y, impo- tence minimal 6 months)
Follow Up
2wk – 11 mo
Source -SC Type – Passage, dose, Route, Repeat, Interval
T: UCB SC -His tos- tem, ABO, HLA- ABC, DR, and sex- matched – 15MC: saline Injection – CC -1x
Other T2DM Related Therapy
T and C:PST, D-SBGM-MA
T2DM Related Outcome
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.
Ref 26
Diagnosis Number of Cases – Age (Duration of T2DM)
T2DM 315 (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)
Follow Up
12 wk 2y post study
Source -SC Type – Passage, dose, Route, Repeat, Interval
MPC- P(?) Rexleme- strocel-L – mesoblas Inc, cryo-thawedT1=0.3 M/kg T2=1 M/kg T3=2 M/kg C= placebo IV- 45 minutes 1X
Other T2DM Related Therapy
T and C: L, PST, BGM-RT
T2DM Related Outcome
Tr: HbA1c – reduced – at all time points after week 1, C: a small increase in HbA1cClinical 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.
Ref 27
Diagnosis Number of Cases – Age (Duration of T2DM)
T2DM413 (T), 13 (C) 10-58 y (0.5 – 11 y)
Follow Up
1y
Source -SC Type – Passage, dose, Route, Repeat, Interval
Hu fetal liver HSC – 35-55 M (20% CD34)- cryo-thawedSaline (C) IV – 1x
Other T2DM Related Therapy
T and C: BGM-FU
T2DM Related Outcome
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.
Reference (Ref) number, T2DM = Type 2 diabetes mellitus, treatment control allocation: 1 patient option, 2 successive: 2 Treatment – 1 Control, others: random, 3 single-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 = intravenous, P = passage, BW = body weight, B = billion, vit. = vitamin, SPDA = superior pancreaticoduodenal artery, UCB = umbilical cord blood, CC = corpora cavernosa (penile root clamped with a band for 30 min), MPC = mesenchymal progenitor cell, cryo = cryopreserved, hu = human, HSC = hematopoietic 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 agents, except thiazolidinediones in cases of unacceptable hyperglycemia, FU = follow-up.
Current Stem Cell Research & Therapy, 2018(13)"Towards Standardized Stem Cell Therapy in Type 2 Diabetes Mellitus: A Systematic Review"Jeanne Adiwinata Pawitan, Zheng Yang, Ying Nan Wu, and Eng Hin Lee
[20] Hu J, Li C, Wang L, et al. Long-term effects of autologous bone marrow mononuclear cell implantation for type 2 diabetes mellitus. Endocr J 2012; 59(11): 1031-9.
[21] Wu Z, Cai J, Chen J, et al. Autologous bone marrow mononuclear cell infusion and hyperbaric oxygen therapy in type 2 diabetes mellitus: an open-label, randomized controlled clinical trial. Cytotherapy 2014; 16: 258-65.
[22] Bhansali A, Asokumar P, Walia R, et al. Efficacy and safety of autologous bone marrow-derived stem cell transplantation in type 2 diabetes mellitus patients: a randomized placebo-controlled study. Cell Transplant 2014; 23(9): 1075-85.
[23] Bhansali A, Upreti V, Khandelwal N, et al. Efficacy of autologous bone marrow-derived stem cell transplantation in type 2 diabetes mellitus patients. Stem Cells Dev 2009; 18(10): 1407-16.
[24] Hu J, Wang Y, Gong H, et al. Long-term effects and safety of Wharton's jelly-derived mesenchymal stem cells in type 2 diabetes. Experimental and Therapeutic Medicine 2016; 12(3): 1857-66.
[25] Bahk JY, Jung JH, Han H, Min SK, Lee YS. Treatment of diabetic impotence with umbilical cord blood stem cell intracavernosal transplant: preliminary report of 7 cases. Exp Clin Transplant 2010; 8(2): 150-60.
[26] Skyler JS, Fonseca VA, Segal KR, et al. Allogeneic mesenchymal precursor cells in type 2 diabetes: A randomized, placebo-controlled, dose-escalation safety and tolerability pilot study. Diabetes Care 2015; 38(9): 1742-9.
[27] Ghodsi M, Heshmat R, Amoli M, et al. The effect of fetal liver-derived cell suspension allotransplantation on diabetic patients: first year of follow-up. Acta Med Iran 2012; 50(8): 541-6.
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