Intralymphatic eASC Administration in Healthy Volunteers

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)

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

Study Overview

• Status: Completed
• Conditions: Localized Adverse Reaction to Administration of Drug
• Intervention / Treatment: Genetic: eASC; Drug: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Pamplona, Spain, 31008
    • Unidad de Investigación Clínica de la Clínica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: eASC; 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.	Genetic: eASC; 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.; Other Names: Allogenic Stem Cells
PLACEBO_COMPARATOR: Placebo; 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	Drug: Placebo; 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; Other Names: HypoThermosol HTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local and systemic reaction to administration procedure	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.	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic parameters	Detection of reactive cells and antibodies against eASC; Lymphocyte subpopulations studies	29 days

Collaborators and Investigators

• Sponsor: Tigenix S.A.U.
• Investigators: Principal Investigator: Belén Sádaba, MD, Unidad de Investigación Clínica de la Clínica Universidad de Navarra

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (ESTIMATE): December 6, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Cx621-0101