Clinical trial NCT01743222: Intralymphatic eASC Administration in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Localized Adverse Reaction to Administration of Drug
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local and systemic reaction to administration procedure
timeFrame: 29 days
Secondary outcomes:
measure: Pharmacodynamic parameters
timeFrame: 29 days
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Unidad de Investigación Clínica de la Clínica Universidad de Navarra
Study officials:
affiliation: Unidad de Investigación Clínica de la Clínica Universidad de Navarra
name: Belén Sádaba, MD
role: PRINCIPAL_INVESTIGATOR
References: