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Also known as Allogenic Stem Cells
eASC · 1 trial · 1 indication
* 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.
| Arm | Type | Description |
|---|---|---|
| eASC | EXPERIMENTAL | eASC * First cohort (3 volunteers, first volunteer is not randomized to detect any acute reaction): injection of 2.5 millions of eASCs suspended in 0.25 ml of HTS per lymph node, total dose 5 millions of cells. * Second cohort (3 volunteers, first volunteer is not randomized to detect any acute reaction): injection of 5 millions of eASCs suspended in 0.5 ml of HTS per lymph node, total dose 10 millions of cells. |
| Placebo | PLACEBO_COMPARATOR | * First cohort (2 volunteers): injection of 0.25 ml of Hypo Thermosol (HTS) per lymph node * Second cohort (2 volunteers): injection of 0.5 ml of Hypo Thermosol (HTS) per lymph node |
| Name | Type | Description |
|---|---|---|
| eASC | GENETIC | * 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. |
| Placebo | DRUG | * 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 |
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 u...
eASC is an investigational gene therapy developed by Takeda Pharmaceutical Company Limited. It is being studied in the setting of localized adverse reactions to drug administration, a condition describing reactions that occur at the site where a drug is given. eASC has been tested in a Phase 1 clinical trial.
eASC is being studied for localized adverse reaction to administration of drug, a condition involving reactions at the site where a drug is administered. It is an investigational gene therapy and is not an approved treatment. Its only recorded clinical study enrolled healthy adult volunteers rather than patients with an active disease.
eASC is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program for this gene therapy candidate.
eASC is in Phase 1 clinical development. Its single recorded trial, NCT01743222, has been completed. The program enrolled 10 participants in a placebo-controlled, randomized design that was not double blinded. eASC remains investigational and has not been approved for any use.
eASC has been studied in one clinical trial, NCT01743222, titled Intralymphatic eASC Administration in Healthy Volunteers. The Phase 1 study was completed, enrolled 10 healthy adult participants of any sex, and was conducted in Spain. It used a randomized, placebo-controlled design without double blinding.