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Table 1 Summary of clinical studies with autologous and allogeneic MSCs

From: Allogeneic vs. autologous mesenchymal stem/stromal cells in their medication practice

Disease/condition

Auto/allo

Source

Study category/

Single dose of MSCs

Therapeutic effect

References

Phase

(× 106 cells)

Cardiomyopathy

Auto

BM

Cohort trial

0.5–1.0/kg or 2.0–3.0/kg

Improvement of clinical symptoms and left ventricular function in patients with chronic severe refractory dilated cardiomyopathy

[44]

Auto

BM

Randomized and controlled trial

3.08 ± 0.52

No improvement in myocardial viability and function in acute STEMI patients

[45]

Auto

BM

Phase I trial

N/A

Cardiac function and quality of life improved in patients with ischemic heart disease undergoing cardiac surgical revascularization at one-year follow-up

[46]

Auto

BM

Phase I/II trial

61.5/10–16 viable sites

Improvement in cardiac performance, left ventricular remodeling, and patient quality of life

[47]

Auto

BM

Randomized and controlled trial

77.5 ± 67.9 (inter-quartile range 53.8)

Improvement in end-systolic volume, EF, stroke volume, cardiac output and myocardial mass at 6 months follow-up in MSC-treated patients with chronic ischaemic heart failure

[48]

Allo

BM

Phase I trial

Dose-ranging (0.5, 1.6 and 5/kg)

Improvement in left ventricular EF and remodeling in MSC-treated patients with acute myocardial infarction

[49]

Allo vs. auto

BM

Phase I/II

100/10 LV sites

Safety of the intervention of allo or auto MSCs and great improvement in EF, 6MWT, MLHFQ, and endothelial restoration in allo compared to auto MSC injection in patients with chronic non-ischemic dilated cardiomyopathy

[50]

Allo vs. auto

BM

Phase I/II

Serially escalated: 20, 100, or 200/10 LV sites

Improvement in functional status and quality of life in patients with ischemic cardiomyopathy

[51]

Lupus/lupus nephritis

Auto

BM

Case series study

N/A

No change in SLE activity indexes but increase in T regulatory cells during 14 weeks of follow-up

[57]

Allo

BM

Case series study

1.5/kg

Complete or partial remission of SLE after MSC infusion through a 9-month follow-up

[61]

Allo

BM

Phase I/II

1.0/kg

Improvement of clinical outcomes and decrease of serological autoimmune markers at 1-year follow-up

[62]

Allo

UC

Phase I/II

1.0/kg

Mixed clinical outcomes presented, as showed 32.5% and 27.5% of patients with MCR and PCR to MSC infusion, respectively, and 12.5% and 16.7% of patients with disease relapse at 9 and 12 months of follow-up, respectively

[63]

DM/DM complication

Auto

BM

Randomized and controlled trial

N/A

Improvement of healing in type 2 DM patients with critical limb ischemia after 24 weeks of follow-up

[70]

Auto

BM

Phase I

N/A

Safe and effective therapeutic option for Bullosis diabeticorum

[71]

Auto

BM

Pilot trial

3/kg

Therapeutic safety and effectiveness in diabetic retinopathy

[72]

Allo

BM

Phase I/II

Dose-escalating, 0.3, 1.0 or 2.0/kg

Safety and feasibility of MSC therapy for type 2 DM during a 12-week period

[73]

Allo

WJ

Phase I/II

1.0/kg

Therapeutic potential in type 2 DM, as showed the improvement in laboratory parameters and systemic inflammation

[74]

Allo

BM

Phase I/II

150 or 300

Improvement in glomerular filtration rate at 12 weeks post-infusion in patients with DM nephropathy

[75]

Allo

UC

Phase I/II

1.1/kg

Metabolic improvement in type 1 DM patients treated with MSC transplantation in combination with auto BM mononuclear cells

[76]

Allo vs. auto

AT

Open-labeled and two-armed trial

103.14 mL with 2.65 ± 0.8 × 104 ISCs/kg or 95.33 mL with 2.07 ± 0.67 × 104 ISCs/kg

Reduction in insulin requirement and a better long-term hyperglycemia control in type 1 DM patients treated with co-infusion of auto insulin-secreting MSCs and BM-derived HSCs, compared with allo stem cell therapy

[77]

Bone/cartilage repair

Auto

BM

Phase I/II

10 or 100

Clinical and functional improvement of knee osteoarthritis after intra-articular injection of MSCs versus hyaluronic acid during follow-up of 12 months

[83]

Auto

BM

Phase I/II

10 or 100

Clinical and functional improvement of knee osteoarthritis after intra-articular injection of MSCs versus hyaluronic acid during follow-up of 4 years

[84]

Auto

AT

Phase IIb

100

Clinical and functional improvement and pain relief in patients with knee osteoarthritis at 6 months of follow-up

[85]

Auto

AT

Phase IIb

50

Clinical and functional improvement and cartilage regeneration in patient with knee osteoarthritis at 12 months of follow-up

[86]

Allo

BM

Phase II

Dose escalation: 20, 50, 75, or 150

Treatment of knee osteoarthritis with a twenty-five-million-cell dose of MSCs shown a trend toward pain reduction

[87]

Allo

BM

Phase I/II

40

Improvement of both pain and cartilage quality without major adverse events in patients with knee osteoarthritis

[88]

Allo

AT

Randomized and controlled trial

3.9 or 6.7

Improvement in pain scores and quantitative MRI assessments

[89]

Allo

Placenta

Pilot trial

50–60

Safety in intra-articular injection of MSCs and clinical improvements at 24-week follow-up

[90]

Allo

UC

Phase I/II

20

Improvement in pain and clinical outcomes in osteoarthritis patients

[91]

Cancer

Auto

BM

Phase I/II

1.0–2.2/kg

Rapid hematopoietic recovery after co-infusion of auto MSCs and auto peripheral blood progenitor cells in patients with advanced breast cancer

[94]

Auto

BM

Phase I

1.0 or 1.5/kg

Safety and feasibility of MSC infusion in combination with ganciclovir in patients with advanced gastrointestinal adenocarcinoma

[95]

Auto

BM

Phase I/II

3.0/kg

Safe and tolerable treatment with MSC infusion in combination with ganciclovir in patients with advanced gastrointestinal adenocarcinoma

[96]

Allo

BM

Phase I

1.0 or 2.0/kg

Safe MSC infusion in prostate cancer patients but no homing of MSCs to the primary tumors at sufficient levels

[97]

Allo

UC

Cohort study

1.14/kg

Enhancement of hematopoietic recovery and reduction of GVHD incidence in acute leukemia children when co-transfusion of MSCs and HSCs

[98]

Allo

UC

Cohort study

N/A

Enhancement of hematopoietic recovery when co-transplantation of MSCs and cord blood in high-risk leukemia patients

[110]

Allo

BM

Retrospective study

6.81/kg

Response rate to MSC infusion among 50% patients with steroid-refractory acute GVHD III/IV

[111]

Tissue fibrosis

Auto

BM

Phase II

50

Histological improvement in 54.5% patients with alcoholic liver cirrhosis following MSC therapy

[112]

Auto

BM

Phase I

100

Improvement in laboratory parameters such as liver function and quality of life for patients with liver cirrhosis

[113]

Auto

BM

Phase II

50

Reduction of hepatic fibrosis and improvement of liver function in patients with liver cirrhosis

[114]

Allo

BM

Phase I

20, 100, or 200

Safety of a single of MSC infusion up to 2 × 108 cells/infusion in IPF patients

[115]

Allo

Placenta

Phase Ib

1.0 or 2.0/kg

Feasibility and short-term safety of MSC infusion in patient with IPF

[116]

Allo

UC

Phase I/II

1.0/kg

Improvement of lung function and computed tomography imaging after MSC infusion combined with plasmapheresis in systemic sclerosis patients

[117]

  1. 6MWT Six Minute Walk Test, Allo allogeneic, AT adipose tissue, Auto autologous, BM bone marrow, BMDM diabetes mellitus, EF ejection fraction, HSCs hematopoietic stem cells, IPF idiopathic pulmonary fibrosis, ISCs insulin-secreting MSCs, kg kilogram body weight, LV left ventricular, MCR major clinical response, MLHFQ Minnesota Living with Heart Failure Questionnaire, MRI magnetic resonance imaging, N/A not available, PCR partial clinical response, SLE systemic lupus erythematosus, STEMI ST-segment elevation myocardial infarction, UC umbilical cord, WJ Wharton’s jelly