Table 1.
Application of AT-MSCs and/or their secretome in diseases related to angiogenic disorders.
| Study Number/Status | Type of Disease | Type of Therapy | Patients | Results | Ref. |
|---|---|---|---|---|---|
| Not reported Completed |
Nonhealing diabetic foot ulcers (>3 cm in diameter) | Local injections of autologous adipose-derived stromal vascular fraction (SVF) cells (EPCs and MSCs), phase 1 study; injection into the target foot of a total dose of 30 × 106 SVF cells | 63 patients with type 2 diabetes and underlying microangiopathy |
Improved ulcer healing: closure response rates among evaluable patients between 86% and 93% at the 6- and 12-month endpoints; changes in the vascular bed beneath the ulcer and structural characteristics of the arteries supplying the foot |
[94] |
| KB/27/2015 Bioethics committee at the Regional Specialist Hospital, Research and Development Center in Wroclaw, Poland Completed |
Chronic venous stasis ulcers | Subcutaneous administration to the tissues surrounding the ulcers and under the ulcer bed of autologous AT-MSCs (3.0 × 105 to 2.3 × 107 cells) | 11 patients (12 ulcers) | Improvement in clinical condition observed in 75% of ulcers; complete healing occurred in 25% of ulcers | [96] |
|
NCT04746599 Recruiting ClinicalTrials.gov |
Critical limb ischemia | Autologous fat grafting | 20 participants | No results posted | |
|
NCT04661644 Recruiting ClinicalTrials.gov |
Critical limb ischemia | Clusters of adipose-derived mesenchymal stem cells (dose: 1 × 107 cells/1 mL/vial, phase 1; and 1 × 108 cells/1 mL/vial, phase 2), phase 1/2a clinical trial | 20 participants | No results posted | |
|
NCT04466007 Recruiting ClinicalTrials.gov |
Critical ischemia of the lower limbs in diabetic patients without the possibility of revascularization | Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly (low and high doses) | 90 participants | No results posted | |
|
NCT03968198 Recruiting ClinicalTrials.gov |
Critical limb ischemia and peripheral artery disease | Autologous intramuscular administration of adipose tissue-derived mesenchymal stromal/stem cells (ASCs), phase 2 study | 43 participants | No results posted | |
|
NCT01824069 Completed ClinicalTrials.gov |
Nonrevascularizable critical ischemia of the lower limbs | Intramuscular injection of autologous adult mesenchymal stem cells derived from adipose tissue (1 × 106/kg), phase 1 and 2a study | 10 participants | 7 patients were followed-up after the treatment for 1 year (phase 1b study). A statistically significant improvement in health-related quality of life in the post-treatment period was observed. An ankle-brachial index and clinical behavior of the limb improved during the follow-up. | [97] |
|
NCT01745744 Completed ClinicalTrials.gov |
Critical chronic ischemic syndrome of the lower limb in nondiabetic patients | Infusion of mesenchymal stem cells derived from adipose tissue administered intraarterially: 0.5 × 106 cells/kg of patient weight and 1 × 106 cells/kg of patient weight, phase 2 study | 33 participants | No results posted | |
|
NCT01663376 Completed |
Critical Limb Ischemia | Intramuscular injection of autologous adipose derived mesenchymal stem cells. Dose: 1 × 108–3 × 108 cells | 20 participants | Autologous AT-MSC implantation effectively increases blood flow. Above 66% of patients with non-healing ulcers experienced ulcer healing, only in the cases with an initially necrotic foot, no observable tissue regeneration occurred. There was clinical improvement in 100% of patients with a diabetic foot (3 patients) and in 58.3% of patients with Buerger’s Disease (7 patients) | [98] |
|
NCT01302015 Completed ClinicalTrials.gov |
Buerger’s disease (thromboangiitis obliterans) | RNL-Vascostem (autologous adipose tissue-derived mesenchymal stem cells) dosage: intramuscular infusion, 5 × 106 cells/kg | 15 participants | ||
|
NCT04569409 Recruiting ClinicalTrials.gov |
Diabetic foot ulcer | Application of a hydrogel sheet (ALLO-ASC-DFU) containing allogenic adipose-derived mesenchymal stem cells to diabetic grade 2 foot ulcer, phase 3 study | 104 patients | No results available yet | |
|
NCT04497805 Recruiting ClinicalTrials.gov |
Diabetic foot ulcer | Application of a hydrogel sheet (ALLO-ASC-DFU) containing allogenic mesenchymal stem cells to diabetic grade 2 foot ulcer, phase 2 study | 64 participants | No results available yet | |
|
NCT04457037 Completed ClinicalTrials.gov |
Trophic ulcer | Patients with trophic ulcers received standard treatment and autologous adipose-derived mesenchymal stem cells | 18 participants | No results available yet | |
|
NCT03276312 Completed ClinicalTrials.gov |
Minor amputations of diabetic foot | Lipogems–local injection of autologous micro-fragmented adipose tissue | 112 participants | After 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed compared to the control group. A significant improvement in terms of physical health-related quality of life and a significant reduction of the hospital length of stay was reported. | [99,100] |
|
NCT03183648 Active, not recruiting ClinicalTrials.gov |
Burn | Application of a hydrogel sheet (ALLO-ASC-DFU) containing allogenic adipose-derived mesenchymal stem cells | 30 participants | No results available yet | |
|
NCT04280003 Recruiting ClinicalTrials.gov |
Ischemic stroke | Intravenous treatment with allogenic adipose tissue-derived stem cells in a single dose of one million cells per kg, phase 2 study | 30 participants | No results available yet | [101] |
|
NCT02387723 Completed ClinicalTrials.gov |
Heart failure | Patients with heart failure treated with culture-expanded adipose tissue-derived mesenchymal stem cells from healthy donors. The cells were injected directly into the myocardium | 10 participants | Four out of ten patients developed donor-specific de novo HLA class I antibodies, and two other patients had donor-specific antibodies at baseline. None of the patients had any clinical symptoms or changes in biochemical or inflammatory parameters. The cardiac function tended to improve after AD MSC treatment at 6-month follow-up. | [102] |
|
NCT01678534 Completed ClinicalTrials.gov |
Ischemic Stroke | Intravenous treatment with allogeneic stem cells from adipose tissue, phase 2 study | 19 participants | No results posted | [103] |
|
NCT01449032 Completed ClinicalTrials.gov |
Chronic ischemic heart disease (coronary artery disease, CAD) | Intramyocardial injections of autologous VEGF-A165-stimulated adipose-derived stem cells (ASCs), phase 2 study | 60 participants | Intramyocardially delivered ASC treatment was safe but did not improve exercise capacity compared to placebo in a pilot study. After a 3-year follow-up, patients receiving ASCs had improved cardiac symptoms and unchanged exercise capacity, in contrast to deterioration in the placebo group | [104,105] |
|
NCT04388761 Recruiting ClinicalTrials.gov |
Ischemia reperfusion injury in patients with a kidney allograft | AMSC treatment via direct injection into the kidney parenchyma and intra-arterial infusion, phase 2 study | 15 participants | No results posted | |
|
NCT01257776 Completed ClinicalTrials.gov |
Critical limb ischemia (CLI) in diabetic patients | Intra-arterial administration of autologous adipose-derived mesenchymal stem cells, phase 1 study | 33 participants | No results posted | |
|
NCT03865394 Completed ClinicalTrials.gov |
Chronic wounds in diabetic foot syndrome | Application of allogeneic adipose-derived mesenchymal stem cells in fibrin gel | 46 participants | No results posted | |
|
NCT03183726 Completed ClinicalTrials.gov |
Diabetic foot ulcer | Application of ALLO-ASC-DFU (a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells), phase 1 study | 4 participants | No results posted | |
|
NCT03754465 Recruiting ClinicalTrials.gov |
Diabetic foot ulcer | Application of an ALLO-ASC-DFU sheet to diabetic foot ulcer (a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells), phase 2 study | 44 participants | No results posted | |
|
NCT03370874 Active, not recruiting ClinicalTrials.gov |
Diabetic foot ulcer | Application of an ALLO-ASC-DFU sheet to diabetic foot ulcer (a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells), phase 3 study | 164 participants | No results posted | |
|
NCT02394873 Completed ClinicalTrials.gov |
Deep second-degree burn wound | Application of an ALLO-ASC-DFU sheet (a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells), phase 1 study | 5 participants | No results posted | |
|
NCT05165459 Recruiting ClinicalTrials.gov |
Venous keg ulcer | Venous leg ulcer treatment with adipose SVF (autologous adipose stromal vascular fraction) administered locally into the target ulcer. | 10 participants | No results posted | |
|
NCT04569409 Recruiting ClinicalTrials.gov |
Diabetic Wagner grade 2 foot ulcers | Application of an ALLO-ASC-DFU sheet (a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells), phase 3 study | 104 participants | No results posted |