Intralymphatic eASC Administration in Healthy Volunteers

Localized Adverse Reaction to Administration of Drug Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743222
• Other study ID #: Cx621-0101
• Status: Completed
• Phase: Phase 1
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: April 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Localized Adverse Reaction to Administration of Drug

Intervention

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

Locations

Country	Name	City	State
Spain	Unidad de Investigación Clínica de la Clínica Universidad de Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Tigenix S.A.U.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacodynamic parameters	Detection of reactive cells and antibodies against eASC; Lymphocyte subpopulations studies	29 days