Localized Adverse Reaction to Administration of Drug
Conditions
Brief 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.
Interventions
GENETICeASC
* 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.
DRUGPlacebo
* 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
Sponsors
Tigenix S.A.U.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 55 both included * Inform Consent Form signed * Body Mass Index (BMI) between 19 and 29 kg/m2 * Presence of, at least, one lymph node of 1cm in its larger diameter in each inguinal location. It has to be accessible for administration after its localization using ultrasound scan.
Exclusion criteria
* Pregnant (positive to urine pregnancy test) or breastfeeding women. * Subjects with history of any organic or psychic pathology in their records, physical exploration or any complementary test. * Any relevant current pathology, including cancer, liver pathology, gastrointestinal dysfunction, renal alteration, respiratory pathology or active acute infectious problems. * Chronic disorders or previous recurrent like hypertension, infections, cardiovascular, respiratory, endocrine, neurologic, hematologic, renal or liver disorders. * Subjects treated four weeks before the first administration with any drug, medicinal plant or Consumer Health Care in a continue routine. It is not consider
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local and systemic reaction to administration procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic parameters | 29 days | * Detection of reactive cells and antibodies against eASC * Lymphocyte subpopulations studies |
Countries
Spain
Outcome results
None listed