Intralymphatic eASC Administration in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01743222|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : March 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Localized Adverse Reaction to Administration of Drug||Genetic: eASC Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|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)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
Other Name: Allogenic Stem Cells
Placebo Comparator: Placebo
Other Name: HypoThermosol HTS
- Local and systemic reaction to administration procedure [ Time Frame: 29 days ]
- 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 ]
- Detection of reactive cells and antibodies against eASC
- Lymphocyte subpopulations studies
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743222
|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|