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Table 2 Registered Cinical Trials

From: Adipose-derived stem cells for treatment of chronic ulcers: current status

Study Type of stem cell and application method Design Condition Trial institution NCT number and duration period Status
A) Safety and effect of adipose tissue derived mesenchymal stem cells implantation in patients with critical limb ischemia Autologous adipose-derived stem cells (ADSC) from lipoaspirate (not further detailed).
Intramuscular injection.
Allocation: non-randomized
Control group: none
Blinding: none (open label)
Follow-up: 3 months
Estimated enrollment: 20
Critical limb ischemia Pusan National University Hospital, Korea NCT01663376
January 2009 to April 2011
Status: completed.
Study published in Circulation Journal Vol. 76, July 2012 [29]
B) The role of lipoaspirate injection in the treatment of diabetic lower extremity wounds and venous stasis ulcers Autologous lipoaspirate with no further ADSC isolation.
Implantation in single tunnels radially around each wound spaced at 5–10 mm apart and approximately 3–5 cm in length
Allocation: randomized
Control group: sterile tumescence solution
Blinding: single (outcomes assessor)
Follow-up: 12 months
Estimated enrollment: 250
Diabetic and venous stasis wounds Washington DC Veterans Affairs Medical Center, Columbia, USA NCT00815217
February 2009 to February 2010
Status: unknown.
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than 2 years
Last update: December 2008
C) Application of cell regeneration therapy with mesenchymal stem cells from adipose tissue in critical chronic ischemic syndrome of lower limbs (CLI) in nondiabetic patients. Autologous ADSC (not further detailed).
Infusion of mesenchymal stem cells from adipose tissue administered intraarterially
Allocation: randomized three armed (high vs. low-dose vs placebo)
Control group: conventional treatment
Blinding: none (open label)
Follow-up: 12 months
Estimated enrollment: 30 (10 in each arm)
Critical limb ischemia Hospital San Lazaro and University Hospital Virgen Macarena, Sevilla, Spain NCT01745744
February 2011 to December 2017
Status: this study is ongoing, but not recruiting participants.
Last update: September 2017
D) Stem cell therapy for patients with vascular occlusive diseases such as diabetic foot Autologous mesenchymal stem cells (not further detailed).
Application method not detailed
Phase: 1
Allocation: non-randomized
Blinding: none (open label)
Control group: none
Follow-up: 6 months
Estimated enrollment: 20
Diabetic foot and lower limb ischemia Chinese PLA General Hospital, China NCT02304588
January 2013 to December 2015
Status: this study is currently recruiting participants.
Last update: December 2014
E) Treatment of hypertensive leg ulcer by adipose tissue grafting (Angiolipo) Autologous ADSC harvested from autologous lipoaspirate. (not further detailed).
Application method not detailed
Phase: 1
Allocation: non-randomized
Blinding: none (open label)
Control group: none
Follow-up: 6 months
Estimated enrollment: 10
Hypertensive ulcers University Hospital, Caen, France NCT01932021
April 2013 to December 2014
Status: completed.
Study published July 2017 in Dermatology [34]
F) Adipose derived regenerative cellular therapy of chronic wounds Autologous ADSC from autologous lipoaspirate. (not further detailed).
Multiple injections of ASC into the periphery and debrided surfaces of chronic wounds
Phase: 2
Allocation: non-randomized
Blinding: none (open label)
Control group: none
Follow-up 3 months
Estimated enrollment: 25
Chronic wounds Tower Outpatient Clinic, Los Angeles, California, USA NCT02092870
September 2013 to September 2015
Status: unknown.
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than 2 years.
Last update: March 2014
G) To evaluate the safety and efficacy of IM and IV administration of autologous ADMSCs for treatment of CLI Autologous stromal vascular fraction and autologous adipose derived MSC (not further detailed).
Injected intravenously and intramuscularly vs intramuscularly only
Allocation: randomized (autologous stromal vascular fraction vs autologous adipose derived MSCs)
Blinding: none (open label)
Primary purpose: treatment
Control group: no treatment
Follow-up 9 months
Estimated enrollment: 60
Critical limb ischemia Kasiak Research Pvt. Ltd., India NCT02145897
August 2014 to August 2015
Status: unknown.
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than 2 years.
Last update: May 2014
H) A clinical study using adipose-derived stem cells for diabetic foot Autologous ADSC from lipoaspirate (not further detailed).
Injections to the wound
Allocation: randomized
Control group: saline
Blinding: none (open label)
Follow-up: 3 months
Estimated enrollment: 240
Peripheral vascular disease, ischemia, and diabetic foot The Third Affiliated Hospital of Southern Medical University, Guangzhou, Guangdong, China NCT02831075
January 2015 to December 2018
Status: this study is currently recruiting participants.
Last update: April 2017
I) Adipose-derived stromal cells (ASCs) and pressure ulcers Autologous ADSC from lipoaspirate (not further detailed).
ADSC injected into a fibrin sealant and applied to the wound
Allocation: randomized
Control group: placebo
Blinding: quadruple (participant, care provider, investigator, outcomes assessor)
Follow-up: 6 months
Estimated enrollment: 12 (6 in each arm)
Stage 3 and 4 pressure ulcers Mayo Clinic, Florida, USA NCT02375802
July 2015 to July 2017
Status: this study is currently recruiting participants.
Last update: September 2016
J) Effectiveness and safety of adipose-derived regenerative cells for the treatment of critical lower limb ischemia Autologous ADSC extracted from lipoaspirate by enzymatic digestion (nor further detailed).
10 mL of autologous ADSC injected intramuscularly
Phase: 1
Allocation: non-randomized
Blinding: none (open label)
Control group: none
Follow-up: 24 weeks
Estimated enrollment: 9
Critical limb ischemia, arteriosclerosis obliterans, peripheral arterial disease Thromboangiitis obliterans, diabetic angiopathies Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation, Russia NCT02864654
July 2016 to July 2018
Status: this study is enrolling participants by invitation only.
Last update: August 2016
K) Assessment of the efficacy and tolerance of sub-cutaneous re-injection of autologous adipose-derived REGEnerative Cells in the Local Treatment of Neuropathic Diabetic Foot ulcERs (REGENDER) Autologous ADSC from lipoaspirate (not further detailed).
Injections to the wound
Phase: 2
Allocation: non-randomized
Blinding: none (open label)
Control group: none
Follow-up: 20 weeks
Estimated enrollment: 45
Diabetic foot ulcer Assistance Publique Hopitaux De Marseille, France NCT02866565
February 2017 to November 2019
Status: not yet recruiting
Last update: August 15, 2016
L) Healing chronic venous stasis wounds with autologous cell therapy Autologous ADSC isolated from lipoaspirate by Transpose® RT System (InGeneron Inc., Texas, USA).
Subcutaneous injection around the rim of the wound
Phase: 2
Allocation: randomized
Blinding: none (open label)
Control group: no treatment
Follow-up: 12 months
Estimated enrollment: 36 (24 cases, 12 controls)
Chronic venous stasis wounds Sanford USD Medical Center, Sioux Falls, South Dakota, USA NCT02961699
June 2017 to January 2020
Status: this study is currently recruiting participants
Last update: August 2017
M) Clinical application of mesenchymal stem cells seeded in chitosan scaffold for diabetic foot ulcers Autologous mesenchymal stem cell seeded in curcumin-loaded chitosan nanoparticles into collagen-alginate.
Application method not detailed
Phase: 1
Allocation: non-randomized
Blinding: none (open label)
Control group: none
Follow-up: 12 months
Estimated enrollment: 40
Diabetic foot ulcer Assiut University, Assiut, Republic of Egypt NCT03259217
October 2017 to January 2019
Status: this study is not yet open for participant recruitment.
Last update: August 2017
N) Safety of adipose-derived stem cell stromal vascular fraction Autologous ADSC from lipoaspirate (not further detailed).
Injections to the wound
Phase: 1
Allocation: non-randomized
Blinding: none (open label)
Control group: none
Follow-up: 20 weeks
Estimated enrollment: 10
Abnormally healing wounds, scars, soft tissue defects Forest Hill Institute of Aesthetic Plastic Surgery, Toronto, Ontario, Canada NCT02590042
October 2017 to January 2021
Status: this study is not yet open for participant recruitment.
Last update July 2017