Intralymphatic eASC Administration in Healthy Volunteers - Full Text View

Purpose

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

Condition	Intervention	Phase
Localized Adverse Reaction to Administration of Drug	Genetic: eASC Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
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)

Further study details as provided by Cellerix:

Primary Outcome Measures:

Local and systemic reaction to administration procedure [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
- 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.

Secondary Outcome Measures:

Pharmacodynamic parameters [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Detection of reactive cells and antibodies against eASC
- Lymphocyte subpopulations studies

Enrollment:	10
Study Start Date:	January 2012
Study Completion Date:	June 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: HypoThermosol HTS

Arms

Assigned Interventions

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 Name: 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 Name: HypoThermosol HTS

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743222

Locations

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

Sponsors and Collaborators

TiGenix S.A.U.

Investigators

Principal Investigator:

Belén Sádaba, MD

Unidad de Investigación Clínica de la Clínica Universidad de Navarra

More Information

No publications provided

Responsible Party:	Cellerix ( TiGenix S.A.U. )
ClinicalTrials.gov Identifier:	NCT01743222 History of Changes
Other Study ID Numbers:	Cx621-0101
Study First Received:	August 24, 2012
Last Updated:	March 5, 2013
Health Authority:	Spain: Agencia Española de Medicamentos y Productos Sanitarios

ClinicalTrials.gov processed this record on May 16, 2013