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| Sponsor: | Pluristem Ltd. |
|---|---|
| Information provided by (Responsible Party): | Pluristem Ltd. |
| ClinicalTrials.gov Identifier: | NCT00951210 |
Purpose
The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral Artery Disease Peripheral Vascular Disease Critical Limb Ischemia |
Biological: PLX-PAD |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Intramuscular (IM) Injections of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia. PLX-PAD Are Mesenchymal-Like Stromal Cells Derived From a Full Term Placenta. |
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PLX-PAD low dose
IM injection Single treatment; multiple injections
|
Biological: PLX-PAD
IM injection
|
|
Experimental: PLX-PAD high dose
IM injection Double treatment; multiple injections
|
Biological: PLX-PAD
IM injection
|
Eligibility| Ages Eligible for Study: | 40 Years to 81 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Cardiology PC | |
| Birmingham, Alabama, United States, 35211 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
More Information
| Responsible Party: | Pluristem Ltd. |
| ClinicalTrials.gov Identifier: | NCT00951210 History of Changes |
| Other Study ID Numbers: | 1202-2 |
| Study First Received: | August 3, 2009 |
| Last Updated: | November 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Peripheral Artery Disease Peripheral Vascular Disease Critical limb ischemia |
|
Ischemia Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Pathologic Processes |
Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases |