Back to resultsTreatment of PAD by Platelet Lysate for Therapeutic Angiogenesis
Primary Purpose
Critical Limb Ischemia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Platelet lysate
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Platelet lysate, Critical limb ischemia, Peripheral arterial disease
Eligibility Criteria
Inclusion Criteria:
- 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.
- Established Peripheral arterial disease, clinically and hemodynamically confirmed as per Rutherford 3, 4 and
- History of intermittent claudication for > eight weeks.
- Limited exercise due to moderate to severe claudication.
- Resting ankle brachial index (ABI) < 0.85, toe pressure ≤ 60 mm Hg, Toe brachial index (TBI) <0.6, or Trans-cutaneous oxygen pressure (TcPO2) ≤ 60 mmHg in the foot.
- Not eligible for surgical or radiological revascularization.
- In case of diabetic patients, he/she should be on medication and fairly controlled (HbA1c <10%).
- Normal liver enzymes, serum creatinine < 1.4
- Normal platelet count.
- On regular medication for hypertension if any.
- No evidence of malignancy
- Low Questionnaire scores.
- Body mass index <30.
Exclusion Criteria:
- 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.
- Chronic inflammatory disease
- History of stroke or myocardial infarction ( < 3 months).
- Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).
- Lab values for
- Hemoglobin <10 g/dl.
- Platelet count <100,000.
- Prothrombin time/ partial thromboplastin time (PT/PTT)> 3 seconds.
- Alanine aminotrasferase (ALT) and aspartatet aminotrasferase (AST) > 1.5x of the normal lab value.
- Creatinine ≥ 1.4
- Poorly controlled diabetes (HbA1c ≥10)
- Bilirubin > 1.5x of the normal lab value.
- Systemic autoimmune disease.
- Receiving immunosuppressant medications.
- Uncontrolled hypertension or hypotension.
- Abdominal aortic aneurism > 5 cm.
- Active or untreated Tuberculosis.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Platelet lysate injection
Arm Description
Injection of platelet lysate intramuscularly in the gastrocnemius muscle
Outcomes
Primary Outcome Measures
Assessment the safety of platelet lysate injection
Patients will be assessed for any relevant adverse event resulting from the platelet lysate injection
Secondary Outcome Measures
Assessment the efficacy of platelet lysate injection
Assessing the therapeutic benefit of all four platelet lysate injections by ankle brachial index (ABI).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02941419
Brief Title
Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis
Official Title
Safety and Efficacy of Platelet Lysate for Therapeutic Angiogenesis in Patients With Peripheral Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 5, 2013 (Actual)
Primary Completion Date
September 15, 2016 (Actual)
Study Completion Date
February 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jordan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Induction of autologous angiogenesis in patients with critical limb ischemia using platelet lysate.
Detailed Description
Ten male and female patients diagnosed with Peripheral artery disease (PAD), will be recruited. This diagnosis will be based on medical history, physical examinations, laboratory tests, and specific diagnostic tests. Patients qualified for this study, are patients with distal extremity ischemia indicated by claudication and rest pain present for a minimum of 4 weeks without evidence of improvement in response to conventional drug therapy; showed angiographic evidence of PAD in the affected limb; and were not candidates for surgical revascularization. Platelet lysate will be injected intramuscularly at different sites of the gastrocnemius muscle. The purpose of this study is to evaluate the safety and efficacy of platelet lysate injections into ischematic limbs of patients with PAD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
Platelet lysate, Critical limb ischemia, Peripheral arterial disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet lysate injection
Arm Type
Experimental
Arm Description
Injection of platelet lysate intramuscularly in the gastrocnemius muscle
Intervention Type
Biological
Intervention Name(s)
Platelet lysate
Intervention Description
Autologous intramuscular platelet lysate injection for patients with peripheral arterial disease
Primary Outcome Measure Information:
Title
Assessment the safety of platelet lysate injection
Description
Patients will be assessed for any relevant adverse event resulting from the platelet lysate injection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment the efficacy of platelet lysate injection
Description
Assessing the therapeutic benefit of all four platelet lysate injections by ankle brachial index (ABI).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Established Peripheral arterial disease, clinically and hemodynamically confirmed as per Rutherford 3, 4 and
History of intermittent claudication for > eight weeks.
Limited exercise due to moderate to severe claudication.
Resting ankle brachial index (ABI) < 0.85, toe pressure ≤ 60 mm Hg, Toe brachial index (TBI) <0.6, or Trans-cutaneous oxygen pressure (TcPO2) ≤ 60 mmHg in the foot.
Not eligible for surgical or radiological revascularization.
In case of diabetic patients, he/she should be on medication and fairly controlled (HbA1c <10%).
Normal liver enzymes, serum creatinine < 1.4
Normal platelet count.
On regular medication for hypertension if any.
No evidence of malignancy
Low Questionnaire scores.
Body mass index <30.
Exclusion Criteria:
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.
Chronic inflammatory disease
History of stroke or myocardial infarction ( < 3 months).
Bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).
Lab values for
Hemoglobin <10 g/dl.
Platelet count <100,000.
Prothrombin time/ partial thromboplastin time (PT/PTT)> 3 seconds.
Alanine aminotrasferase (ALT) and aspartatet aminotrasferase (AST) > 1.5x of the normal lab value.
Creatinine ≥ 1.4
Poorly controlled diabetes (HbA1c ≥10)
Bilirubin > 1.5x of the normal lab value.
Systemic autoimmune disease.
Receiving immunosuppressant medications.
Uncontrolled hypertension or hypotension.
Abdominal aortic aneurism > 5 cm.
Active or untreated Tuberculosis.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis
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