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Table 4 Some of MSC-based Clinical Data For Scleroderma

From: Mesenchymal stem cell as a novel approach to systemic sclerosis; current status and future perspectives

Source of cells or tissues References Type of the study The site of stem cell injection Included patients Clinical outcomes Post-intervention complications
Fat tissue auto graft ± PRP (Daumas et al. 2020) Case report -PRP/microfat in nasolabial folds and chin and cheekbones
-PRP/emulsified fat in upper lip, lower lip, and submucosally at the level of the oral commissure
1 patient Affected by systemic sclerosis–related perioral thickening ↑skin trophicity -minimal Bruising, pain and swelling in donor areas
-superficial hematomas in the injection site
(Del Papa et al. 2019) Clinical trial the base of the finger 25/13 patients with IDU(fat/control groups) ↑IDU healing
↓pain
↑the number of capillaries in the affected digit
NR
Fat tissue auto graft/ AD-MSC (Onesti et al. 2016) Clinical trial Subcutaneous peri-oral location 5/5 affected by dcSSc (fat/ AD-MSC groups) ↑subjective wellness of the skin in the perioral areas
↑IvMHISS score
↑mouth opening
↑VAS score
*the results were not significantly different between two groups
NR
AD-MSC (Khanna et al. 2018) Clinical trial Subcutaneous in all fingers 48/40With impairment of hand function(diffuse and limited sclerosis cases)(AD-MSC / control groups) ↑CHFS score
↓RCS
↑SHAQ score
Improvement in EQ-5D-5L assessment(diffuse subjects)
↑Patient Global Assessment of SSc activity(diffuse subjects)
-Upper respiratory tract infection
-Arthralgia
-Cellulitis
-Pain in extremity
-Hypoesthesia
The process is reported to be safe
ADSVF ± PRP (Virzì et al. 2017) Case report Subcutaneous in peri-oral and malar area 6 patients affected by dcSSc ↑skin elasticity (improvement of the opening and extension benchmarks of the labial rhyme)
↓longitudinal skin wrinkles of the upper lip more harmonious, less tense, ↑capillary density
↓vascular ectasia
↑neoangiogenesis
NR
(Song et al. 2017) Case report Subcutaneous in metacarpophalangeal of both hands and the amputation stump of the left middle finger, and under a skin necrosis in the right hand. 62 patients affected by dcSSc There was no need to further amputation because of gangrene, ulcer and impaired wound healing. NR
(Daumas et al. 2017) Clinical trial All fingers 12 patients with hand disability of at least 20 points using CHFS. ↑SHAQ score
↑CHFS score
↑grip strength
↑pinch strength
↓ RCS
↓DU
NC in Mean global disease severity score
NR
UC-MSC (Zhang et al. 2017) Clinical trial NR 14 patients affected by dcSSc ↓skin thickness
↑lung function (in 3 ILD affected patients)
↑ulcer healing
↓Serum anti-Scl70 autoantibody titer
↓TGFβ and VEGF levels
NC in IFN-γ, IL-4 or IL-10
-upper respiratory tract infections -diarrhea
(Liang et al. 2018) Retrospective cohort NR 39 patients affected by SSc mesenchymal stem cell infusion is a safe therapy for patients with autoimmune diseases The incidence of Hyper acute (fever, headache, palpitation and so on) and acute (hair loss, facial rash and so on) adverse effects, transplantation-related mortality, infection and malignancy are not high. Survival rate in1 year after infusion is almost 70%
(Wehbe et al. 2016) Case report intravenous 2 affected by progressive, refractory scleroderma ↓dyspnea (first subject)
Pulmonary hypertension was normalized (first subject)
↓skin contracture (first subject)
pericardial effusion was resolved (first subject)
↓joint pain (second subject)
ability to exert was normalized (second subject)
↓arthritis (second subject)
↓Raynaud’s phenomenon pain (second subject)
↑mobility and function(both subjects after second injection)
NR
  1. PRP Platelet-Rich Plasma, IDU Indolent Digital Ulcers, IvMHISS Italian version of Mouth Handicap in Systemic Sclerosis Scale, VAS Visual Analogue Scale, AD Adipose, EQ-5D-5L EuroQol-5-Dimensions-5-Level, dcSSc Diffuse cutaneous Systemic Sclerosis, SSc Systemic Sclerosis, SHAQ Scleroderma Health Assessment Questionnaire, CHFS Cochin Hand Function Scale, RCS Raynaud’s Condition Score, DU Digital Ulcer, ILD Interstitial Lung Disease, TGFβ Transforming Growth Factor beta, VEGF Vascular Endothelial Growth Factor, IL Interleukin, MSC Mesenchymal Stem Cell, NR Not Reported, NC No Change