Clinical trial • Phase IV • Cardiology

SALINE for Chronic limb ischemia (critical limb ischemia)

Phase IV trial of SALINE for Chronic limb ischemia (critical limb ischemia).

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Chronic limb ischemia (critical limb ischemia)
Trial Stage
Phase IV
Drug Modality
Cell therapy | Other

Key dates

Initial CTIS Submission Date
29-01-2025
First CTIS Authorization Date
04-02-2025

Trial design

SALINE (SOLUTION FOR INJECTION) is listed as a product; details on dose and schedule are not specified-controlled Phase IV trial across 1 site in Spain.

Comparator
SALINE (SOLUTION FOR INJECTION) is listed as a product; details on dose and schedule are not specified
Target Sample Size
21

Eligibility

Recruits 21 No vulnerable population selected. Signed informed consent required from participants. No assent procedures or specific vulnerable-population consent arrangements are described..

Pregnancy Exclusion
Pregnant women or women in fertile age whithout an adecuate anticonceptive method
Vulnerable Population
No vulnerable population selected. Signed informed consent required from participants. No assent procedures or specific vulnerable-population consent arrangements are described.

Inclusion criteria

  • {"criterion_text":"- age among >= 18 and <= 90 years old\n- advanced chronic ischemia (fontaine III-IV class and Rutherford IV-V), with risk of amputation of at least one limb\n- No option of surgical or endovascular revascularization\n- Life expenctancy > 2 years\n- Normal hematological parameters: o Leukocytes >= 3000 o Neutrophyles >= 1500 o Platelets >= 140000\n- Signed informed consent"}

Exclusion criteria

  • {"criterion_text":"- history of solid neoplasia or hematological disease (myeloproliferative disease, myelodisplastic syndrome or leukemia)\n- Rutherford VI stage\n- Severe Cardiac insuficiency (NYHA IV) or ejection fraction < 30%\n- Patients with malignant ventricular arrythmia or unstable angina\n- Diagnosis of deep vein thrombosis on last 3 months\n- Active systemic infection\n- Concomitant Therapy with hyperbaric oxygen, agents against angiogenesis or COX-II inhibitors\n- Body mass Index > 40 Kg/m2\n- Infection by VIH, B or C hepatitis, or syphilis\n- Problems with follow-up\n- CVA or miocardial infarct on last 3 months\n- Pregnant women or women in fertile age whithout an adecuate anticonceptive method\n- To be treated with an Advanced Therapy Medicine Product in the last 12 months."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Anatomic and functional changes derived from the vasculo/angiogenesis induced by somatic cell therapy: improve in ankle/brachial index, digit/brachial index, transcutaneous oxygen measurement, ischemic ulcer size and maximum walking distance until claudication","definition_or_measurement_approach":"Measured as improvements in ankle/brachial index, digit/brachial index, transcutaneous oxygen measurement, reduction in ischemic ulcer size, and increase in maximum walking distance until claudication."}

Recruitment

Planned Sample Size
21
Recruitment Window Months
47
Consent Approach
Signed informed consent is required from participants. A Subject information and informed consent form document is listed for publication. No details on assent, age-specific consent, proxy consent or languages available are provided.

Geography

Total Number Of Sites
1
Total Number Of Participants
21

Spain

Earliest CTIS Part Ii Submission Date
29-01-2025
Latest Decision Or Authorization Date
04-02-2025
Processing Time Days
6
Number Of Sites
1
Number Of Participants
21

Sites

Site Name
Hospital Universitario Central De Asturias
Department Name
Unidad de Terapia Celular y Medicina Regenerativa
Contact Person Name
Marcos Pérez Basterrecha
Contact Person Email
utcmr.huca@gmail.com
Number Of Participants
21

Sponsor

Primary sponsor

Full Name
Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
SALINE
Active Substance
SALINE
Modality
Other
Routes Of Administration
INTRAARTERIAL USE
Route
INTRAARTERIAL USE
Maximum Dose
1 (maxDailyDoseAmount), maxTotalDoseAmount 3, maxTreatmentPeriod 3 (time unit unspecified)
Investigational Product Name
bone-marrow nuclear cells
Active Substance
bone-marrow nuclear cells
Modality
Cell therapy
Routes Of Administration
INTRAARTERIAL USE
Route
INTRAARTERIAL USE

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