Autologous bone marrow derived stem cell therapy in patients with type 2 diabetes mellitus - defining adequate administration methods

doi:10.4239/wjd.v8.i7.381

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World Journal of Diabetes

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1948-9358

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Randomized Controlled Trial

World J Diabetes. Jul 15, 2017; 8(7): 381-389
Published online Jul 15, 2017. doi: 10.4239/wjd.v8.i7.381

Table 1 Comparison of baseline characteristics

Parameter	Group I	Group II	Group III	Group IV	P value
Age	57.83 ± 5.84	49.85 ± 9.63	53.28 ± 7.29	55.7 ± 7.7	0.351
Sex	M-4, F-3	M-6, F-1	M-6, F-1	M-5, F-2	0.592
Duration of diabetes (in years)	19.5 ± 5.54	14.28 ± 6.77	14.28 ± 5.64	19.6 ± 6.4	0.213
Insulin requirement	43.66 ± 5.35	39.71 ± 3.81	45 ± 6.57	43.86 ± 4.50	0.893
Duration of insulin (in years)	3.75 ± 1.72	4.47 ± 4.1	6.66 ± 4.54	4.4 ± 2.7	0.742
Weight	79 ± 18.89	72.14 ± 8.41	75.78 ± 9.95	77.7 ± 13	0.75
BMI	28.83 ± 4.26	26.57 ± 2.63	26.85 ± 3.97	29.6 ± 1.9	0.349
Body fat	31.5 ± 8.57	29.57 ± 5.38	33.14 ± 7.26	35.1 ± 2.5	0.452
Waist circumference	98.5 ± 9.46	92.57 ± 6.10	98.42 ± 9.51	101.6 ± 4.1	0.152
FPG	106.66 ± 14.36	103.42 ± 16.89	89.71 ± 9.21	103.5 ± 6.0	0.112
HbA1c	6.8 ± 0.18	6.4 ± 0.16	6.7 ± 0.15	6.6 ± 0.24	0.75
FPI (uU/mL)	123 ± 92	57 ± 48	22 ± 5	14.1 ± 4.3	0.17
HOMA-IR%	11.72 ± 5.39	3.31 ± 1.11	5.92 ± 0.67	4.6 ± 1.5	0.446
HOMA-B%	146.26 ± 56.44	40.75 ± 12.02	129.57 ± 65.20	77.8 ± 22.4	0.451
Fasting C-pep (ng/mL)	2.97 ± 1.51	1.28 ± 0.14	1.41 ± 0.25	1.1 ± 0.2	0.221
Stimulated C-peptide (ng/mL)	4.26 ± 1.59	2.63 ± 0.23	2.37 ± 0.36	2.1 ± 0.3	0.192
Number of BMMNCs infused	4.9 ± 3.10 × 10⁸	12.04 ± 4.84 × 10⁸	6.88 ± 2.30 × 10⁸	NA	NA

BMI: Body mass index; FPG: Fasting plasma glucose; HbA1c: Glycosylated hemoglobin; HOMA-IR: Homeostasis model assessment insulin resistance index; BMMNCs: Bone marrow mononucleated cells; HOMA-B: Homeostasis model assessment beta cell function.

Table 2 Procedural details in Group I, II and III patients were as follows

Parameter	Group I	Group II	Group III
Volume of marrow aspirated (mL)	149 ± 60	222 ± 22.97	199 ± 49.91
Aspiration - Unilateral/Bilateral	U/L-3, B/L-4	B/L-7	U/L-4, B/L-3
Bone marrow TNC count	11.72 ± 6.36 × 10⁸	20.28 ± 8.55 × 10⁸	11.72 ± 3.03 × 10⁸
Bone marrow MNC count	4.9 ± 3.10 × 10⁸	12.04 ± 4.84 × 10⁸	6.88 ± 2.30 × 10⁸
Bone marrow CD 34+ cell count	0.71% ± 0.45%	0.87% ± 0.35%	0.58% ± 0.30%
Procedure time (min)	57 ± 18	50 ± 8	38 ± 18
Artery cannulated	SPD-5, SMA-2	Splenic-7	IV route
Catheter change required	1 case- multiple times	Nil	NA
SUV max at Pancreas at 30 min (mean ± SD)	21 ± 38	3.4 ± 3.34	1.56 ± 0.34

NA: Not applicable.

Table 3 Insulin sensitivity indices in Group I

Time	0 mo (mean ± SE)	6 mo (mean ± SE)	12 mo	P value
FPI (uU/mL)	123 ± 91.87	75.83 ± 58.69		0.707
HOMA-IR%	11.72 ± 5.39	6.96 ± 1.32		0.368
HOMA-B%	146.26 ± 56.44	63.33 ± 13.99		0.183
Fasting C-peptide (ng/mL)	2.97 ± 1.51	2.94 ± 0.80		0.973
Stimulated C-peptide (ng/mL)	4.26 ± 1.59	4.23 ± 0.84		0.989

HOMA-IR: Homeostasis model assessment insulin resistance index; HOMA-B: Homeostasis model assessment beta cell function.

Table 4 Insulin sensitivity indices in Group II

Time	0 mo (mean ± SE)	6 mo (mean ± SE)	P value
FPI (uU/mL)	57.33 ± 48.19	71.04 ± 38.88	0.62
HOMA-IR %	3.31 ± 1.11	4.76 ± 0.45	0.223
HOMA-B %	40.75 ± 12.02	46.86 ± 2.62	0.664
Fasting C-peptide (ng/mL)	1.282 ± 0.14	1.896 ± 0.29	0.103
Stimulated C-peptide (ng/mL)	2.63 ± 0.23	3.008 ± 0.26	0.395

HOMA-IR: Homeostasis model assessment insulin resistance index; HOMA-B: Homeostasis model assessment beta cell function.

Table 5 Insulin sensitivity indices in Group III

Time	0 mo (mean ± SE)	6 mo (mean ± SE)	P value
FPI (uU/mL)	21.94 ± 5.12	16.45 ± 4.39	0.434
HOMA-IR%	5.92 ± 0.67	6.13 ± 1.5	0.918
HOMA-B%	129.57 ± 65.20	59.58 ± 22.96	0.206
Fasting C-peptide (ng/mL)	1.415 ± 0.25	2.49 ± 0.74	0.263
Stimulated C-peptide (ng/mL)	2.37 ± 0.36	3.48 ± 0.87	0.325

HOMA-IR: Homeostasis model assessment insulin resistance index; HOMA-B: Homeostasis model assessment beta cell function.

Table 6 Insulin sensitivity indices in Group IV

Time	0 mo (mean ± SE)	6 mo (mean ± SE)	P value
FPI (uU/mL)	14.1 ± 4.3	18.2 ± 4.3	0.525
HOMA-IR%	4.6 ± 1.5	4.9 ± 1.2	0.895
HOMA-B%	77.8 ± 22.4	91.7 ± 14.6	0.618
Fasting C-peptide (ng/mL)	1.1 ± 0.2	1.5 ± 0.4	0.287
Stimulated C-peptide (ng/mL)	2.1 ± 0.3	2.8 ± 0.8	0.408

HOMA-IR: Homeostasis model assessment insulin resistance index; HOMA-B: Homeostasis model assessment beta cell function.

Table 7 Insulin dose (U/d) before and after autologous bone marrow derived stem cell therapy in Group I

Patient	Baseline	3 mo	6 mo	12 mo	18 mo	24 mo
1	32	22	16	Nil	Nil	Nil
2	66	55	53	53	50	_
3	30	20	16	14	-	-
4	46	26	20	20	-	-
5	40	18	12	-	-	-
6	48	8	10	-	-	-
7	Lost to FU
Mean ± SE	44 ± 5	25 ± 7	21 ± 7
P value		0.011	0.003

Table 8 Insulin dose (U/d) before and after autologous bone marrow derived stem cell therapy in Group II

Patient	Baseline	3 mo	6 mo	12 mo
1	40	27	16	12
2	46	44	38	34
3	25	18	8	5
4	30	20	20	18
5	40	34	30	-
6	55	40	-	-
7	45	27	-	-
Mean ± SE	40 ± 4	30 ± 4	22 ± 5
P value		0.003	0.01

Table 9 Insulin dose (U/d) before and after autologous bone marrow derived stem cell therapy in Group III

Patient	Baseline	3 mo	6 mo	12 mo	18 mo
1	53	48	36	27	18
2	47	34	15	12	-
3	51	25	Nil	Nil	-
4	75	78	86	70	-
5	26	26	18	24	-
6	25	20	18	-	-
7	38	32	30	-	-
Mean ± SE	45 ± 7	38 ± 8	34 ± 11
P value		0.087	0.137

Table 10 Insulin dose (U/d) before and after autologous bone marrow derived stem cell therapy in Group IV

Patient	Baseline	3 mo	6 mo
1	30	30	32
2	37	25	23
3	46	40	34
4	68	55	57
5	41	26	20
6	45	41	39
7	40	49	24
Mean ± SE	44 ± 5	38 ± 4	33 ± 5
P value		0.999	0.021

Table 11 Comparison of different case arms (Group I, II and III) with control arm (Group IV) at zero month

Parameter	Group I	Group II	Group III	Group IV	P value Group I	P value Group II	P value Group III
Insulin requirement	44 ± 5	40 ± 4	45 ± 7	44 ± 5	0.979	0.541	0.927
HbA1c	6.8 ± 0.18	6.4 ± 0.16	6.7 ± 0.15	6.6 ± 0.24	0.983	0.453	0.9
HOMA IR%	11.72 ± 5.39	3.31 ± 1.11	5.92 ± 0.67	4.6 ± 1.5	0.544	0.327	0.333
HOMA-B%	146.2 ± 56.44	40.75 ± 12.02	129.57 ± 65.20	77.8 ± 22.4	0.593	0.212	0.559
Fasting C-peptide (ng/mL)	2.97 ± 1.51	1.282 ± 0.14	1.415 ± 0.25	1.1 ± 0.20	0.174	0.087	0.139
Stimulated C-peptide (ng/mL)	4.26 ± 1.59	2.63 ± 0.23	2.37 ± 0.36	2.1 ± 0.3	0.144	0.132	0.324

HbA1c: Glycosylated hemoglobin; HOMA-IR: Homeostasis model assessment insulin resistance index; HOMA-B: Homeostasis model assessment beta cell function.

Table 12 Comparison of different case arms (Group I, II and III) with control arm (Group IV) at 6 mo

Parameter	Group I	Group II	Group III	Group IV	P value Group I	P value Group II	P value Group III
Insulin requirement	21 ± 7	22 ± 5	34 ± 11	33 ± 5	0.174	0.183	0.69
HbA1c	6.5 ± 0.16	6.7 ± 0.12	6.7 ± 0.21	6.6 ± 0.22	0.816	0.704	0.779
HOMA IR%	6.96 ± 1.32	4.76 ± 0.45	6.13 ± 1.5	4.9 ± 1.2	0.404	0.358	0.322
HOMA B%	63.33 ± 13.99	46.86 ± 2.62	59.58 ± 22.96	91.7 ± 14.6	0.096	0.29	0.213
Fasting C-peptide (ng/mL)	2.94 ± 0.80	1.896 ± 0.29	2.49 ± 0.74	1.5 ± 0.4	0.091	0.34	0.187
Stimulated C-peptide (ng/mL)	4.23 ± 0.84	3.008 ± 0.26	3.48 ± 0.87	2.8 ± 0.	0.14	0.566	0.412

HbA1c: Glycosylated hemoglobin; HOMA-IR: Homeostasis model assessment insulin resistance index; HOMA-B: Homeostasis model assessment beta cell function.

Table 13 Change in HbA1c % before and after autologous bone marrow derived stem cell therapy in Group I

Patient	Baseline	3 mo	6 mo	12 mo	18 mo	24 mo
1	7.2	5.7	7.1	6.4	6.8	7.3
2	6.7	6.2	6.7	6.9	6	-
3	6	-	6.4	5.7	-	-
4	7	6.8	6.6	-	-	-
5	6.1	6.3	5.9	-	-	-
6	6.9	6.5	6.4	-	-	-
7	Lost to FU
Mean ± SE	6.8 ± 0.18	6.3 ± 0.18	6.5 ± 0.16
P value		0.164	0.355

Table 14 Change in HbA1c % before and after autologous bone marrow derived stem cell therapy in Group II

Patient	Baseline	3 mo	6 mo	12 mo	18 mo
1	7	7.1	7	7.4	6.5
2	6.2	6.4	6.5	6.7	7.7
3	6.6	6.5	6.5	6.5	-
4	5.6	7.5	7	6.4	-
5	6.6	6.7	6.5	-	-
6	6.4	6.3	-	-	-
7	6.5	5.7	-	-	-
Mean ± SE	6.4 ± 0.16	6.6 ± 0.21	6.7 ± 0.12
P value		0.573	0.351

Table 15 Change in HbA1c % before and after autologous bone marrow derived stem cell therapy in Group III

Patient	Baseline	3 mo	6 mo	12 mo	18 mo
1	6.3	6.2	5.9	7.1	5.9
2	6.8	5.8	6.8	6.3	-
3	6.9	6.9	6.9	7.4	-
4	6.8	6.7	7.2	7	-
5	6.9	7.2	7.5	7.5	-
6	6	6	6.2	-	-
7	7.2	6.8	6.4	-	-
Mean ± SE	6.7 ± 0.15	6.5 ± 0.19	6.7 ± 0.21
P value		0.28	0.999

Table 16 Change in HbA1c % before and after autologous bone marrow derived stem cell therapy in Group IV

Patient	Baseline	3 mo	6 mo
1	6.6	6.3	5.5
2	7	7.1	6
3	7	7	6.7
4	7.5	7.8	7
5	6	6.9	7.1
6	6.8	7.2	6.8
7	5.6	5.5	7
Mean ± SE	6.6 ± 0.6	6.8 ± 0.7	6.6 ± 0.2
P value		0.258	0.408

Citation: Sood V, Bhansali A, Mittal BR, Singh B, Marwaha N, Jain A, Khandelwal N. Autologous bone marrow derived stem cell therapy in patients with type 2 diabetes mellitus - defining adequate administration methods. World J Diabetes 2017; 8(7): 381-389
URL: https://www.wjgnet.com/1948-9358/full/v8/i7/381.htm
DOI: https://dx.doi.org/10.4239/wjd.v8.i7.381