Intralymphatic eASC Administration in Healthy Volunteers

Brief Summary

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)”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2012

Detailed Clinical Trial Description

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

Interventions Used in this Clinical Trial

  • 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.
  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • 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.
  • 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

Outcome Measures for this Clinical Trial

Primary Measures

  • Local and systemic reaction to administration procedure
    • Time Frame: 29 days
      Safety Issue?: Yes

Secondary Measures

  • Pharmacodynamic parameters
    • Time Frame: 29 days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • TiGenix S.A.U.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Belén Sádaba, MD, Principal Investigator, Unidad de Investigación Clínica de la Clínica Universidad de Navarra

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01743222