Clinical Trial with Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Progreso Y Salud

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

19 Jan 2024 → ongoing

Decision date (initial)

2024-04-22

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513151-33-00

EudraCT number

2021-001341-12

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Feasibility and Safety

Secondary objectives 1

1. 1. To determine the effect of the experimental treatment on wound closure time compared to the control group. 2. To assess the effect of the experimental treatment on the healing evolution of the lesion, in terms of depth, size, type of edges, tissue and exudate compared to the control group. 3. To assess the effect of the experimental treatment on the concentration of growth factors closely related to wound healing (cytokines IL-6, IL-4, TGF-β1 and IL-10) in the exudate of the lesion in on day 0, +7, +14, +21 and +28 compared to the control group and its possible relationship with the rest of the efficacy parameters. 4. Evaluate the evolution of pain derived from the presence of UVs in the group treated with the PEI, in comparison with the control group. 5. To determine the perceived quality of life after treatment with the experimental treatment compared to the control group.

Conditions and MedDRA coding

Venous ulcer of the lower limbs

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Signing of the informed consent (IC) after reading the patient information sheet. 2. Over 18 years of both sexes. 3. Active or recurrent venous ulcer (C6 according to the CEAC clinical classification, Annex 5)” in the lower extremity with an area between 5-10 cm2. 4. Grade III injury on the Widmer scale. 5. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3.

Exclusion criteria 1

1. 1. Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms. The following comorbidities will be allowed: peripheral vascular disease, coronary heart disease, chronic kidney disease, chronic liver disease, and arterial hypertension. 2. Grade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5). 3. Active neoplasia and/or being treated with cytostatics. 4. Patients undergoing radiotherapy treatment in areas close to the lesion. 5. Clinical signs of colonization or local infection of the lesion. 6. Lymphangitis in the limb to be treated. 7. Chronic lymphedema in the limb to be treated. 8. Venous ulcer grade I or II on the Widmer scale. 9. Lesions close to possible or diagnosed cancerous lesions. 10. Non-localized wounds in the lower extremities. 11. Ongoing systemic infection. 12. Critical ischemia in the lower limbs or other venous diseases of unknown origin. 13. Immunocompromised patients. 14. Dialysis patients. 15. Thalassemia patients. 16. Decompensated heart failure. 17. Pregnant and lactating women. 18. Any other recurrent illness or condition that, in the opinion of the investigator, would make the patient ineligible to participate in the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Feasibility and Safety

Secondary endpoints 1

1. 1.To determine the effect of the IMP on wound closure time compared to control group.2.To assess the effect of the IMP on the healing evolution of the lesion vs control group.3.To assess the effect of IMP on the concentration of GF closely related to wound healing.4.Evaluate the evolution of pain derived from the presence of UVs in the group treated with the IMP vs control group.5.To determine the perceived quality of life after treatment with the IMP vs control group.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Progreso Y Salud

Sponsor organisation

Fundacion Progreso Y Salud

Address

Bloque 2, Calle Americo Vespucio 5, Parque Cientifico Y Tecnologico Cartuja 93 Calle Americo Vespucio 5 Parque Cientifico Y Tecnologico Cartuja 93

City

Sevilla

Postcode

41092

Country

Spain

Scientific contact point

Organisation

Fundacion Progreso Y Salud

Contact name

Olga Fernández López

Public contact point

Organisation

Fundacion Progreso Y Salud

Contact name

Olga Fernández López

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications