Autologous Bone Marrow derived cells for the treatment of chronic arterial Limb Ischemia in patients with high risk of amputation
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- 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
Overview
Brief Summary
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
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
cell therapy and regenerative medicine unit
Scientific
Fundacion Para La Investigacion Y La Innovacion Biosanitaria Del Principado De Asturias