Critical Limb Ischemia Clinical Trial
Official title:
Umbilical Cord Blood Stem Cell Injection for Critical Limb Ischemia
The purpose of this study is to determine whether treatment with umbilical cord blood stem cells will improve blood flow to the most severely affected leg of a participant with medically refractory and non-surgical peripheral vascular disease of the lower extremity.
Umbilical cord blood is a safe alternative source of stem cells used for decades in
hematopoietic stem cell transplants for malignancies. There is also a reported decreased
incidence of acute GVHD compared to matched unrelated donor transplants.A cord blood
registry will be searched for suitable units with compatibility in the ABO and HLA systems.
The minimum total nucleated cell dose required which would be 1.0 x 107/kg, and one unit of
cells will be procured to meet this requirement. Although it is likely that the transplanted
cord blood cells will be rejected over time, we hypothesize that while they remain in the
host's tissue these cells will be producing and releasing cytokines, growth factors and
other humoral factors that might promote vasculogenesis by stimulating endogenous stem cells
and endothelial cells. Since there is no need to collect the patient's own stem cells, the
patient's cardiovascular system will not be subjected to any stress due to the leukapheresis
procedure itself. No injections of exogenous growth factors, which have been associated with
thrombosis, would be required to mobilize the patient's own stem cells. The procedure could
conceivably even be performed in its entirety on an outpatient basis.
A total of 25 patients will be enrolled in the study. Patients will be followed for 24
months after the procedure with evaluation visits one day after the transplant and then at
one month, six, twelve and twenty four months post-treatment. The visit one day after the
transplant will involve a history and physical with a leg exam, a CBC and a chemistry panel
to evaluate for possible infection, or other adverse event.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
| Recruiting |
NCT03668353 -
Recombinant SeV-hFGF2/dF Injection for PAOD
|
Phase 1 | |
| Recruiting |
NCT04110964 -
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
|
Phase 1 | |
| Not yet recruiting |
NCT03994666 -
Cell Therapy in Critical Limb Ischemia
|
Phase 2 | |
| Recruiting |
NCT02389023 -
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
|
N/A | |
| Not yet recruiting |
NCT02498080 -
Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia
|
N/A | |
| Completed |
NCT02539940 -
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
|
||
| Recruiting |
NCT02239419 -
Evaluation of Carbothera in the Treatment of Foot Ulcers
|
N/A | |
| Recruiting |
NCT01938872 -
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
|
N/A | |
| Active, not recruiting |
NCT01211925 -
Distal Venous Arterialisation of Ischemic Limb
|
Phase 2/Phase 3 | |
| Completed |
NCT02454231 -
Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)
|
Phase 2/Phase 3 | |
| Completed |
NCT01758874 -
Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia
|
Phase 2 | |
| Completed |
NCT02475200 -
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
|
||
| Recruiting |
NCT04583436 -
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
|
N/A | |
| Completed |
NCT04071782 -
Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore
|
N/A | |
| Completed |
NCT03669458 -
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
|
N/A | |
| Not yet recruiting |
NCT06007469 -
Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
|
||
| Recruiting |
NCT04110327 -
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
|
||
| Completed |
NCT02260622 -
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
|
Phase 2 | |
| Recruiting |
NCT02054416 -
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
|
N/A |