Lower limbs Chronic Wounds
Conditions
Interventions
Product Name: SUSPENSION OF EXPANDED HUMAN ALLOGENEIC MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: not applicable
CAS N
Sponsors
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes =18 years. 2. Patients presenting at least one chronic ulcer of the lower limbs (venous ulcer) refractory to conventional treatment. Chronic ulcer is understood as a wound that has not culminated the closure process in a period of 6 months, and by conventional treatment to the use of Aquacel, Promogran, Silverderma, Vulcosan type dressings, among others, as well as vacuum therapy VAC, serum Rich in platelets and laminar grafts. NOTE: If the patient has more than one ulcer that meets the inclusion criteria, the ulcer to be treated for the study will be designated at the discretion of the researcher according to his or her criteria. 3. Women of childbearing age must obtain a negative result in a urine pregnancy test performed at the time of inclusion in the study and commit to using an effective contraceptive method for the duration of the study. 4. Size of the ulcer under study:> 5 cm2 but =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Patients under 18 years. 2. Pregnant or breastfeeding women. 3. Patients with chronic treatment of systemic steroids (> 7.5 mg / day) or any other medication that may influence the healing process (systemic, cytotoxic immunosuppressants) at the time of initiation of treatment or during the 4 weeks prior to trial start 4. Patients with bone infection (osteomyelitis) and / or tendon. 5. Patients with direct exposure of muscle, bones and tendons. 6. Patients who have been treated with active wound care agents (such as local antibiotics or silver dressings), within 14 days prior to treatment. 7. Patients with allergies related to antibiotics or any of the components used in the cultivation of ADMSCs and in the formulation of the finished drug (IMP). 8. Patients with diabetes mellitus with blood levels of hemoglobin A1c (HbA1c)> 7.5% in the analysis of the selection period. 9. Patients with blood glucose levels greater than> 450 mg / dl postprandial. 10. Patients with peripheral arterial disease, including intermittent claudication, who need treatment. 11. Patients with active episode in acute acute venous thrombosis treatment. 12. Patients with cancer or cancerous lesions adjacent to the ulcer to be treated. 13. Positive patients for human acquired immunodeficiency virus (HIV). 14. Patients who have undergone previous surgical interventions such as bypass or mesh grafts in the 2 months prior to the application of the medication. 15. Patients who have participated in any other clinical trial during the 3 months prior to the start of treatment and / or have previously received (six months before the start) cell therapy for this pathology six months before the start. 16. Patients with a history of drug or alcohol abuse. 17. Patients who are not able to understand the objective of the study. 17. Any circumstance that in the opinion of the investigator constitutes an impediment to the understanding of the objective of the study, the correct participation of the patient in the study or the fulfillment of the procedures established in the same. 18. Patients who do not agree to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety and tolerability of the administration of allogeneic MSCs derived from adipose tissue (ADMSCs) assembled three-dimensionally in a fibrin matrix obtained from platelet rich plasma (ADMSC-fib) in patients with chronic wounds;Secondary Objective: To assess preliminary efficacy of the investigational product;Primary end point(s): Treatment related Complication rate;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage reduction of ulcer size to 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20 and 24 weeks after treatment. ? Proportion of patients with complete wound closure at 8, 12 and 24 weeks after treatment or at any time until the end of follow-up. ? Time (in days) in which treated ulcers close completely. It will be evaluated from the initial day of treatment until the end of the follow-up (it is not possible to make an a priori specification). ? Proportion of patients with wound closure of 30% at 2, 3, 4, 5, 6, 7, 8, 12, 16, 20 and 24 weeks after treatment or at any time until the end of follow-up. ? Time (in days) in which treated ulcers close to 30%. It will be evaluated from the initial day of treatment until the end of the follow-up (it is not possible to make an a priori specification). ? Assessment of pain reduction: Regarding the baseline caused by the ulcer that will be assessed using the subjective scale at each visit, Visual Analogue Scale (VAS) (from 0 to 100). Anat Anatomo-pathological analysis of the ulcer: two biopsies will be taken from the edge of the ulcer before starting treatment and when the wound has closed at 50%. ? Assessment of the change in quality of life: survey of specific assessment of the quality of life (questionnaire SF-12). The survey will be conducted before treatment and at 4, 12 and 24 weeks after treatment.;Timepoint(s) of evaluation of this end point: 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20 and 24 weeks after treatment. | — |
Countries
Spain
Contacts
Public ContactUNIDAD DE INVESTIGACION CLINICA
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Outcome results
None listed