Overview
Sponsor-declared trial summary
advanced chronic ischemia (fontaine III-IV class and Rutherford IV-V), with risk of amputation of at least one limb
Evaluate the safety, in terms of absence of adverse effects, and the efficacy, in terms of pain decrease, functional improvement and delay or absece of amputation, of the use of BM-MNCs in the treatment of "no option" chronic lim ischemia with risk or amputation. Determine the mot efficient route of administration
Key facts
- Sponsor
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-02-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520937-22-00
- EudraCT number
- 2020-000468-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Evaluate the safety, in terms of absence of adverse effects, and the efficacy, in terms of pain decrease, functional improvement and delay or absece of amputation, of the use of BM-MNCs in the treatment of "no option" chronic lim ischemia with risk or amputation. Determine the mot efficient route of administration
Conditions and MedDRA coding
advanced chronic ischemia (fontaine III-IV class and Rutherford IV-V), with risk of amputation of at least one limb
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- The patient must have: - age among >= 18 and <= 90 years old - advanced chronic ischemia (fontaine III-IV class and Rutherford IV-V), with risk of amputation of at least one limb - No option of surgical or endovascular revascularization - Life expenctancy > 2 years - Normal hematological parameters: o Leukocytes >= 3000 o Neutrophyles >= 1500 o Platelets >= 140000 - Signed informed consent
Exclusion criteria 1
- The patient can not have none of those criteria: - history of solid neoplasia or hematological disease (myeloproliferative disease, myelodisplastic syndrome or leukemia) - Rutherford VI stage - Severe Cardiac insuficiency (NYHA IV) or ejection fraction < 30% - Patients with malignant ventricular arrythmia or unstable angina - Diagnosis of deep vein thrombosis on last 3 months - Active systemic infection - Concomitant Therapy with hyperbaric oxygen, agents against angiogenesis or COX-II inhibitors - Body mass Index > 40 Kg/m2 - Infection by VIH, B or C hepatitis, or syphilis - Problems with follow-up - CVA or miocardial infarct on last 3 months - Pregnant women or women in fertile age whithout an adecuate anticonceptive method - To be treated with an Advanced Therapy Medicine Product in the last 12 months.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAARTERIAL USE
- Max daily dose
- 1
- Max total dose
- 3
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Sponsor organisation
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Address
- Avenida De Roma Sn
- City
- Oviedo
- Postcode
- 33011
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Contact name
- cell therapy and regenerative medicine unit
Public contact point
- Organisation
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Contact name
- Clinical Trials Area
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 21 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PROTOCOLO | 2 |
| Recruitment arrangements (for publication) | HIP Hoja de Informacion del Paciente | 1 |
| Subject information and informed consent form (for publication) | HIP Hoja de Informacion del Paciente | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC | 1 |
| Synopsis of the protocol (for publication) | Resumen del protocolo | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-03 | Spain | Acceptable with conditions 2025-02-04
|
2025-02-04 |