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)
Overview
- Phase
- Phase 1
- Intervention
- eASC
- Conditions
- Localized Adverse Reaction to Administration of Drug
- Sponsor
- Tigenix S.A.U.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Local and systemic reaction to administration procedure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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)
Detailed Description
Phase I, unicentric, single blind, clinical trial with healthy volunteers to determine the feasibility of a new administration technique.
Investigators
Eligibility 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.
Arms & Interventions
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.
Intervention: eASC
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
Intervention: Placebo
Outcomes
Primary Outcomes
Local and systemic reaction to administration procedure
Time Frame: 29 days
* 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 Outcomes
- Pharmacodynamic parameters(29 days)