Clinical trial • Dermatology

Autologous bone marrow mononuclear cells for Hard-to-heal wounds|Difficult-to-heal wounds|Delayed wound healing

Clinical trial of Autologous bone marrow mononuclear cells for Hard-to-heal wounds|Difficult-to-heal wounds|Delayed wound healing. 10 participants.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Hard-to-heal wounds|Difficult-to-heal wounds|Delayed wound healing
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
04-12-2023
First CTIS Authorization Date
22-03-2024

Trial design

Clinical trial across 1 site in Spain.

Target Sample Size
10

Eligibility

Recruits 10 Vulnerable population not selected; no special consent/assent handling mentioned in the record..

Vulnerable Population
Vulnerable population not selected; no special consent/assent handling mentioned in the record.

Recruitment

Planned Sample Size
10
Recruitment Window Months
6

Geography

Total Number Of Sites
1
Total Number Of Participants
10

Spain

Earliest CTIS Part Ii Submission Date
12-12-2023
Latest Decision Or Authorization Date
08-05-2025
Processing Time Days
513
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Hospital Universitario Central De Asturias
Department Name
Unidad de Terapia Celular y Medicina Regenerativa
Principal Investigator Name
Silvia Perez Lopez
Principal Investigator Email
silvia.perez@sespa.es
Contact Person Name
Silvia Perez Lopez
Contact Person Email
silvia.perez@sespa.es
Number Of Participants
10

Sponsor

Primary sponsor

Full Name
Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Autologous bone marrow mononuclear cells in gel dressing
Active Substance
Autologous bone marrow mononuclear cells
Modality
Cell therapy

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