NCT01743222

Intralymphatic eASC Administration in Healthy Volunteers

Cx621-0101 Phase I Clinical Trial in Healthy Volunteers to Evaluate the Feasibility and Safety of the Intralymphatic Administration Technique of Expanded Allogeneic Adipose-derived Stem Cells (eASCs)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tigenix S.A.U. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective is to determine the safety, tolerability and feasibility of the inguinal intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)

Detailed description

Phase I, unicentric, single blind, clinical trial with healthy volunteers to determine the feasibility of a new administration technique.

Conditions

• Localized Adverse Reaction to Administration of Drug

Interventions

Type	Name	Description
GENETIC	eASC	* First cohort: Intra lymph node injection of 2.5 millions of eASCs suspended in 0.5 ml of HypoThermosol per lymph node, total dose 5 millions of cells. * Second cohort: Intra lymph node injection of 5 millions of eASCs suspended in 0.25 ml of HypoThermosol per lymph node, total dose 10 millions of cells.
DRUG	Placebo	* First cohort (2 volunteers): injection of 0.25 ml of HypoThermosol (HTS) per lymph node * Second cohort (2 volunteers): injection of 0.5 ml of HypoThermosol (HTS) per lymph node

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2012-12-06
• Last updated: 2019-04-12

Locations

1 site across 1 country: Spain