Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrin-hyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513151-33-00

Enrollment

Registered

2024-04-22

Start date

2024-01-19

Completion date

Unknown

Last updated

2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous ulcer of the lower limbs

Brief summary

Feasibility and Safety

Detailed description

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.

Interventions

DRUGBioengineered Artificial Mesenchymal Sheet (BAMS)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Feasibility and Safety	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026