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

Advanced Search

BPG is committed to discovery and dissemination of knowledge

Home / Archive / Volume 8, Issue 7

This Article

Academic Content and Language Evaluation of This Article

CrossCheck and Google Search of This Article

Academic Rules and Norms of This Article

Citation of this article

Corresponding Author of This Article

Research Domain of This Article

Article-Type of This Article

Open-Access Policy of This Article

Times Cited Counts in Google of This Article

Number of Hits and Downloads for This Article

Total Article Views (6539)

All Articles published online

The chart showing PDF series, WORD series, HTML series, Tables (1-16) series.

Item

Count

PDF

360

WORD

230

HTML

3087

Tables (1-16)

538

Sum=4215

Publishing Process of This Article

The chart showing Browse series, Download series.

Item

Count

Browse

732

Download

1592

Sum=2324

Jul 15, 2017 (publication date) through Feb 18, 2025

Times Cited of This Article

Times Cited (13)

Journal Information of This Article

Publication Name

World Journal of Diabetes

ISSN

1948-9358

Publisher of This Article

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