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Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy (HULPVAS)

Primary Purpose

Nonrevascularizable Critical Ischemia of the Lower Limbs

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Intramuscular injection of a suspension of adult mesenchymal stem cells derived

About this trial

This is an interventional treatment trial for Nonrevascularizable Critical Ischemia of the Lower Limbs focused on measuring Critical Ischemia, Amputation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed Consent.
> 18 years.
Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb.
Arterial occlusion direct flow or distal femoropopliteal level.
No option for surgical or endovascular revascularization.
Life expectancy exceeding two years.
High probability of need for major amputation at 6 months (CLI nonrevascularizable).
Negative pregnancy test if applicable.

Exclusion Criteria:

Background of hematologic neoplasia or unresolved.
Hipertensión uncontrolled blood (> 180/110).
Severe heart Insuficiencia (New York Heart Association [NYHA] IV) or ejection fraction <30%.
Malignant ventricular, Arritmias.
Trombosis of deep vein the past three months.
active infection.
Infarto infarction or stroke the previous three months.
Medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
Subjects with congenital or acquired immunodeficiencies. Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion, treponema.
Major surgery or severe trauma of the subject in the previous semester.
Administration of any investigational drug at present to three months prior to enrollment for this trial.
Pulmonary heart disease, in the opinion of the investigator, be unstable or is sufficiently serious to dismiss the patient from the study.
Infants or pregnant women.
Adult women of childbearing potential not using effective contraception during the trial

Sites / Locations

Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous mesenchymal stem cells

Arm Description

Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight in a dosis

Outcomes

Primary Outcome Measures

Safety of inject mesenchymal stem cells in MMII

It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial.

Secondary Outcome Measures

Quality of life of patients after treatment

We analyze the quality of life of patients by SF-12 test

Full Information

NCT ID

NCT01824069

First Posted

April 1, 2013

Last Updated

June 14, 2016

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Hospital Universitario La Paz

1. Study Identification

Unique Protocol Identification Number

NCT01824069

Brief Title

Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy

Acronym

HULPVAS

Official Title

Phase IIa Clinical Trial to Safety of Treatment in Critical Ischemia Nonrevascularizable Lower Limb by Mesenchymal Stem Cells

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborators

Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

It has been demonstrated the feasibility, safety and effectiveness of mesenchymal stem cells derived from lipoaspirate for treating various pathologies fistula. With this project we will address a study population with critical ischemia of lower limbs without possibility of revascularization, either by technical criteria (no intervention possible to compensate for the lack of irrigation of a limb) criteria or risk / benefit (intolerable surgical risk for the type of intervention required). It will almost always elderly patients with multiple comorbidities and high surgical risk who have a lower limb ischemia in critical degree, with very high probability of major amputation in the short term or immediate. Hypothesis: mesenchymal stem cells obtained by lipoaspirate expanded "ex vivo", are capable of promoting angiogenesis de novo to improve critical limb ischemia lower nonrevascularizable a safe manner

Detailed Description

The primary endpoint of safety and feasibility study will be done when the patient has received treatment at 12 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All adverse events will be collected during the same time monitoring the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to the study therapy. Secondary endpoints: As part of the evaluation of the quality of life of patients and clinical evaluation of the treatment will be at 6, 9 and 12 months after implantation a Test SF-12, a magnetic resonance angiography, and tissue oximetry records ankle-brachial index

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonrevascularizable Critical Ischemia of the Lower Limbs

Keywords

Critical Ischemia, Amputation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous mesenchymal stem cells

Arm Type

Experimental

Arm Description

Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight in a dosis

Intervention Type

Other

Intervention Name(s)

Intramuscular injection of a suspension of adult mesenchymal stem cells derived

Intervention Description

Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients

Primary Outcome Measure Information:

Title

Safety of inject mesenchymal stem cells in MMII

Description

It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial.

Time Frame

one year

Secondary Outcome Measure Information:

Title

Quality of life of patients after treatment

Description

We analyze the quality of life of patients by SF-12 test

Time Frame

one year

Other Pre-specified Outcome Measures:

Title

Clinical evaluation of patients after treatment

Description

Clinical evaluation of patients after treatment with magnetic resonance angiography, tissue oximetry records and ankle-brachial index.

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Informed Consent. > 18 years. Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb. Arterial occlusion direct flow or distal femoropopliteal level. No option for surgical or endovascular revascularization. Life expectancy exceeding two years. High probability of need for major amputation at 6 months (CLI nonrevascularizable). Negative pregnancy test if applicable. Exclusion Criteria: Background of hematologic neoplasia or unresolved. Hipertensión uncontrolled blood (> 180/110). Severe heart Insuficiencia (New York Heart Association [NYHA] IV) or ejection fraction <30%. Malignant ventricular, Arritmias. Trombosis of deep vein the past three months. active infection. Infarto infarction or stroke the previous three months. Medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study. Subjects with congenital or acquired immunodeficiencies. Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion, treponema. Major surgery or severe trauma of the subject in the previous semester. Administration of any investigational drug at present to three months prior to enrollment for this trial. Pulmonary heart disease, in the opinion of the investigator, be unstable or is sufficiently serious to dismiss the patient from the study. Infants or pregnant women. Adult women of childbearing potential not using effective contraception during the trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis Riera del Moral, Doctor

Organizational Affiliation

Instituto de Investigación Hospital Universitario La Paz

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

12. IPD Sharing Statement

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Treatment CLI Nonrevascularizable Lower Limb With Cell Therapy

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