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Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)

Primary Purpose

Peripheral Arterial Disease

Status

Unknown status

Phase

Phase 1

Locations

Jordan

Study Type

Interventional

Intervention

Platelet lysate

Placebo

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, Platelet lysate

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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 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 (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).

Sites / Locations

Cell Therapy CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Platelet lysate

placebo

Arm Description

A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval

A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Frequency and nature of adverse events occurring during a 6-month period following platelet lysate injection(s). This will be assessed by physical examination combined with a report with chemistry blood tests.

Secondary Outcome Measures

Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI

Positive changes in patients' Ankle brachial index (ABI)

Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure

Positive changes in patients' Toe pressure (mm Hg)

Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2

Positive changes in patients' Transcutaneous oxygen pressure (TcPO2)

Full Information

NCT ID

NCT03297814

First Posted

August 8, 2017

Last Updated

July 23, 2019

Sponsor

Sophia Al-Adwan

1. Study Identification

Unique Protocol Identification Number

NCT03297814

Brief Title

Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)

Official Title

A Randomized, Double Blind, Placebo Controlled Trial, Investigating the Effect of Intramuscular Injection of Allogenic Platelet Lysate for the Treatment of PAD

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 18, 2018 (Actual)

Primary Completion Date

March 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sophia Al-Adwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 then prepared from the tested PRP to be intramuscularly injected in patients with PAD

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

Peripheral arterial disease, Platelet lysate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Platelet lysate

Arm Type

Active Comparator

Arm Description

A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval

Intervention Type

Biological

Intervention Name(s)

Platelet lysate

Intervention Description

Intramuscular injection of platelet lysate

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

intramuscular injection of normal saline

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI

Description

Positive changes in patients' Ankle brachial index (ABI)

Time Frame

12 months

Title

Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure

Description

Positive changes in patients' Toe pressure (mm Hg)

Time Frame

12 months

Title

Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2

Description

Positive changes in patients' Transcutaneous oxygen pressure (TcPO2)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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. 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 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 (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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sofia Adwan, Msc

Phone

00962796175617

sophia.adwan@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdalla Awidi, MD

Organizational Affiliation

Cell Therapy Center

Official's Role

Study Director

Facility Information:

Facility Name

Cell Therapy Center

City

Amman

ZIP/Postal Code

11942

Country

Jordan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sofia Adwan, PhD

Phone

962-6-5355000

Ext

23960

sophia.adwan@gmail.com

First Name & Middle Initial & Last Name & Degree

hanan Jafar, PhD

Phone

00962-6-5355000

Ext

23960

hanan.jafar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)

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