Assessment of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients With Critical Limb Ischemia

• Status: Suspended
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind placebo controlled study to determine the safety and efficacy of Angiogenic Cell Precursors (ACPs) in relieving symptoms of Critical Limb Ischemia in patients treated with standard of care and with no surgical revascularization option. It is assumed that the ACP-treated group will have a lower amputation and death rate as compared to the placebo group. Other hemodynamic, imaging and clinical parameters will also be compared between the two groups. Quality of life assessments will also be performed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hemostemix

Criteria

Inclusion Criteria:

• Patient is diagnosed with critical limb ischemia

• Patient has hemodynamic indicators of severe peripheral arterial disease

• Patient is not a candidate for revascularization treatment options for peripheral arterial disease

• Patient is on standard of care medical therapy for peripheral arterial disease

• Male or female age 18 and above

• Non-pregnant, non-lactating female

• Patient is able to understand and provide a signed informed consent form

Exclusion Criteria:

• Patient having an uncorrected Aorto-Iliac occlusive disease down to the origin of the Profunda-Femoris artery

• Patient who in the opinion of the investigator would require a major amputation within approximately 4 weeks after administration of study treatment.

• Critical Limb Ischemia presenting as severe large ischemic ulcers or dry gangrene proximal to the MTP (Metatarsophalangeal) joints heads or lower extremity wet gangrene

• Lower extremity non-treated active infection

• Hypercoagulable state

• Patient received blood transfusions during the previous 4 weeks

• Patient's condition precludes 2 consecutive attempts of ACPs manufacturing

• Patient unable to communicate

• Major non-vascular operation during the preceding 3 months

• Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure during the preceding 3 months

• Severe aortic stenosis

• Severe renal failure

• Severe hepatic failure

• Anemia

• Major stroke within the preceding 3 months.

• Diagnosis of malignancy within the preceding 3 years

• Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms

• Severe concurrent disease

• Bleeding diathesis.

• Participation at the same time in another stem cell study

• Chronic immunomodulating or cytotoxic drug treatment

• Fever for 2 days prior to the time the patient is about to receive the study treatment

• Life expectancy of less than 6 months

• Patient unlikely to be available for follow-up

• No acute worsening of CLI (Critical Limb Ischemia)