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Autologous Bone Marrow derived cells for the treatment of chronic arterial Limb Ischemia in patients with high risk of amputation
EU CTIS ID: 2025-520937-22-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.