Intralymphatic eASC Administration in Healthy Volunteers

NCT01743222 | Completed Phase 1

• 1 other identifier: Cx621-0101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

Localized Adverse Reaction to Administration of Drug

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacodynamic parameters

  29 days

Study Arms (2)

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.

Genetic: eASC

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

Drug: Placebo

Interventions

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.

Also known as: Allogenic Stem Cells

eASC

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

Also known as: HypoThermosol HTS

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tigenix S.A.U.: lead

Study Sites (1)

Unidad de Investigación Clínica de la Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Interventions

hypothermosol

Study Officials

• Belén Sádaba, MD

  Unidad de Investigación Clínica de la Clínica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: December 6, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

ES (1)