Intralymphatic eASC Administration in Healthy Volunteers
The objective is to determine the safety, tolerability and feasibility of the inguinal intralymphatic administration of expanded allogeneic adipose-derived stem cells (eASCs)
Localized Adverse Reaction to Administration of Drug
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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)|
- Local and systemic reaction to administration procedure [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
- Pain in administration area will be assessed by a visual analogical scale.
- Medical exploration of the administration area will be performed to identify any skin reaction.
- Inguinal scan will be performed to assess any lymphatic node modification.
- Systemic tolerability will be measured by number of AE (Adverse Event) recorded at any time, including any alteration in laboratory parameters and/or physical exploration.
- Pharmacodynamic parameters [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Detection of reactive cells and antibodies against eASC
- Lymphocyte subpopulations studies
|Study Start Date:||January 2012|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Other Name: Allogenic Stem Cells
Placebo Comparator: Placebo
Other Name: HypoThermosol HTS
Phase I, unicentric, single blind, clinical trial with healthy volunteers to determine the feasibility of a new administration technique.
|Unidad de Investigación Clínica de la Clínica Universidad de Navarra|
|Pamplona, Spain, 31008|
|Principal Investigator:||Belén Sádaba, MD||Unidad de Investigación Clínica de la Clínica Universidad de Navarra|