Intralymphatic eASC Administration in Healthy Volunteers

TigenixU

Status and phase: Completed; Phase 1

Conditions: Localized Adverse Reaction to Administration of Drug

Treatments: Drug: Placebo; Genetic: eASC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01743222

Cx621-0101

Details and patient eligibility

About

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

Full description

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria a sporadic medication. The physician will study the interaction between the eASC with this medication.
• History of hypersensibility to drugs.
• Volunteers participants in other clinical trial within 4 months prior the start of the study.
• Blood or derivatives transfusion in 6 months before the trial.
• Known history of abuse of alcohol or other addictive substances(amount of alcohol allow as maximum in this trial is 0.5 liter of wine or two beers or amount in grams equivalent to this of any other alcoholic drink).
• Illegal drugs consumption during the month before the enrollment in the study or positive result to a drug test.
• Positive serology for B hepatitis virus (HbsAg), C hepatitis virus or HIV (Human Inmunodeficiency Virus).
• Subjects whose freedom depends on legal or administrative requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

eASC

Experimental group

Description:

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.

Treatment:

Genetic: eASC

Placebo

Placebo Comparator group

Description:

* 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

Treatment:

Drug: Placebo