Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-16
Brief Title:
Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
Sponsor:
UPECLIN HC FM Botucatu Unesp
Organization:
UPECLIN HC FM Botucatu Unesp
Study Overview
Official Title:
Randomized Prospective Controlled Single-center Open-label Phase II Clinical Trial Aimed at Evaluating the Safety and Efficacy of Autologous Mesenchymal Stem Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Peripheral arterial disease PAD can progress to critical limb ischemia CLI of the affected lower limb characterized by pain at rest ulcerations or gangrene with a high risk of amputation In this phase the best treatment is arterial limb revascularization but this is not always possible or even effective for promoting pain relief healing of ulcers or preventing amputations in addition to the high socioeconomic cost caused by the disease Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out Objective To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers Methods An open randomized clinical study will be performed with 2 groups of 20 patients with CLI in group 1 a fragment of abdominal fat tissue 10g will be collected to obtain mesenchymal stem cells which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb in addition to the application in the form of a personalized curative biological on the wounds Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids Periodic clinical evaluations complementary exams and photographic record will be carried out The main outcome of effectiveness will be partial or total wound healing Safety outcomes will be monitored for infections gangrene amputations and deaths Participants will be monitored for 120 days Major amputation cases will not be included An independent external evaluator and blind to the groups will evaluate the results It is an innovative procedure with high impact and financial return for SUS in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None