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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of PAD by Platelet Lysate for Therapeutic Angiogenesis

NCT02941419

Critical Limb Ischemia

COMPLETED PHASE1/PHASE2

SB-659032 Platelet Aggregation Study

NCT01745458

Atherosclerosis

COMPLETED PHASE1

Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)

NCT02369848

Peripheral Arterial Disease

COMPLETED NA

The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease

NCT05009862

Peripheral Arterial Disease

ACTIVE_NOT_RECRUITING PHASE4

A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients

NCT01499420

Stable Atherothrombotic Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Platelet lysate

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

Group Type ACTIVE_COMPARATOR

Platelet lysate

Intervention Type BIOLOGICAL

Intramuscular injection of platelet lysate

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

intramuscular injection of normal saline

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Platelet lysate

Intramuscular injection of platelet lysate

Intervention Type BIOLOGICAL

Placebo

intramuscular injection of normal saline

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No