Trials / Available
AvailableNCT03746899
Expanded Access for Treatment Use of PLX-PAD in Critical Limb Ischemia (CLI)
Expanded Access to Provide Intramuscular Injections of PLX-PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
- Status
- Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- WideTrial, Inc. · Industry
- Sex
- All
- Age
- 45 Years – 99 Years
- Healthy volunteers
- —
Summary
This is an Expanded Access program (EAP), sponsored by WideTrial for the treatment of critical limb ischemia (CLI). Widetrial, an Expanded Access specialist, has arranged to supply participating sites with PLX-PAD for CLI patients who cannot participate in the ongoing research trial and who seek exploratory treatment options. This program includes FDA-authorized cost recovery, meaning payment is required to cover a portion of the costs of delivering product and complying with regulatory obligations.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PLX-PAD | PLX-PAD cell therapy to be administered via 30 IM injections (0.5 mL each) to the index leg leg per treatment, in each of two treatments, 8 weeks apart |
Timeline
- First posted
- 2018-11-20
- Last updated
- 2019-01-08
Source: ClinicalTrials.gov record NCT03746899. Inclusion in this directory is not an endorsement.