Localized Adverse Reaction to Administration of DrugPhase 1NCT01743222

Intralymphatic eASC Administration in Healthy Volunteers

A Phase 1 study testing eASC in people with Localized Adverse Reaction to Administration of Drug, run by Tigenix S.A.U. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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) Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Localized Adverse Reaction to Administration of Drug
What is being tested?: eASC
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteSpain
Study dates: Jan 2012to Jun 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

Other trials in Spain

About this study

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)

Read the detailed description

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

Conditions: Localized Adverse Reaction to Administration of Drug
Being tested: eASC, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

eASCGenetic
Also called Allogenic Stem Cells
- 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.
PlaceboDrug
Also called HypoThermosol HTS
- 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

Study groups in NCT01743222
Study group	Role	What they receive
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. Receives: 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 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 29 days

Secondary outcomes (1)

Pharmacodynamic parameters
- Detection of reactive cells and antibodies against eASC
- Lymphocyte subpopulations studies
Measured: 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2012

First posted6 Dec 2012 (estimated)
Study startJan 2012
Primary completionMay 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Localized Adverse Reaction to Administration of DrugStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01743222
Sponsor's protocol ID: Cx621-0101
Status last verified: Apr 2019
First submitted: 24 Aug 2012
Last updated: 12 Apr 2019
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01743222
Acronym / sponsor ID: Cx621-0101
Conditions: Localized Adverse Reaction to Administration of Drug
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Tigenix S.A.U.Industry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: May 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 6 Dec 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
eASC	Experimental	Genetic: eASCeASC * 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	Placebo comparator	Drug: 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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
eASCAlso: Allogenic Stem Cells* 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.	Genetic	eASC
PlaceboAlso: HypoThermosol HTS* 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	Drug	Placebo

Primary outcome

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.

1 secondary outcome

Pharmacodynamic parameters
Time frame: 29 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Belén Sádaba, MD principal investigator

Unidad de Investigación Clínica de la Clínica Universidad de Navarra

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing eASC in people with Localized Adverse Reaction to Administration of Drug, run by Tigenix S.A.U. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local and systemic reaction to administration procedure (time frame: 29 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01743222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.