Status:
UNKNOWN
Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)
Lead Sponsor:
Sophia Al-Adwan
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (PAD)
Detailed Description
Allogenic platelet rich plasma (PRP) will be collected from blood group AB donors. This plasma will be tested for the presence of any chronic infectious blood borne disease. Platelet lysate will be t...
Eligibility Criteria
Inclusion
- Competent and willing to give informed consent, and to be available for all baseline treatment and follow up examinations required by the protocol.
- Gender: Male or female.
- Age group \> 50 years.
- Established Critical limb ischemia (CLI), clinically and hemodynamically confirmed as per Rutherford 3, 4 and 5 with angiographic evidence of significant infra-inguinal arterial occlusive disease.
- History of intermittent claudication for \> eight weeks.
- Limited exercise due to moderate to severe claudication.
- Resting ABI \< 0.6, toe pressure ≤ 60 mm Hg, Toe Brachial index (TBI) \<0.6, or TcPO2 ≤ 60 mmHg in the foot.
- Not eligible for surgical or radiological revascularization, and doesn't respond to best standard care delivered as confirmed by a vascular surgeon and/or physician.
- Fairly controlled diabetes (Hemoglobin A1c \<10%).
- Normal liver enzymes, serum creatinine \< 1.4
- Normal platelet count.
- On regular medication for hypertension if any.
- No evidence of malignancy
- Body mass index \<30.
Exclusion
- Women with child bearing potential, pregnant and lactating women.
- Rheumatoid Arthritis.
- History of neoplasm or malignancy in the past 10 years.
- Reported unstable cardiovascular disease, heart failure or symptomatic postural hypotension within 6 months before screening.
- Leg edema
- Inflammatory or progressive fibrotic disorder
- Renal insufficiency or failure
- History of infectious disorder (Human immunodeficiency virus (HIV) and/or hepatitis viruses).
- Chronic inflammatory disease
- History of stroke or myocardial infarction (\< 3 months).
- Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03297814
Start Date
April 18 2018
End Date
May 1 2020
Last Update
July 24 2019
Active Locations (1)
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1
Cell Therapy Center
Amman, Jordan, 11942