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

Sponsor

Sophia Al-Adwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT03297814

Collaborator

(none)

Enrollment

Location

Arms

24.4

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (PAD)

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Biological: Platelet lysate Biological: Placebo	Phase 1/Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 18, 2018

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Platelet lysate A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval	Biological: Platelet lysate Intramuscular injection of platelet lysate
Placebo Comparator: placebo A total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval	Biological: Placebo intramuscular injection of normal saline

Arm

Intervention/Treatment

Active Comparator: Platelet lysate

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

Biological: Platelet lysate

Intramuscular injection of platelet lysate

Placebo Comparator: placebo

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

Biological: Placebo

intramuscular injection of normal saline

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [6 months]
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 [12 months]
Positive changes in patients' Ankle brachial index (ABI)
Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure [12 months]
Positive changes in patients' Toe pressure (mm Hg)
Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2 [12 months]
Positive changes in patients' Transcutaneous oxygen pressure (TcPO2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cell Therapy Center	Amman		Jordan	11942

Sponsors and Collaborators

Sophia Al-Adwan

Investigators

Study Director: Abdalla Awidi, MD, Cell Therapy Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sophia Al-Adwan, Clinical Co-ordinator, University of Jordan

ClinicalTrials.gov Identifier:

NCT03297814

Other Study ID Numbers:

PAD2UJCTC

First Posted:

Sep 29, 2017

Last Update Posted:

Jul 24, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sophia Al-Adwan, Clinical Co-ordinator, University of Jordan

Peripheral arterial disease

Platelet lysate

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of Jul 24, 2019