NCT03297814

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

August 8, 2017

Last Update Submit

July 23, 2019

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial diseasePlatelet lysate

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (3)

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

    12 months

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

    12 months

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

    12 months

Study Arms (2)

Platelet lysate

ACTIVE COMPARATOR

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

Biological: Platelet lysate

placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Platelet lysateBIOLOGICAL

Intramuscular injection of platelet lysate

Platelet lysate
PlaceboBIOLOGICAL

intramuscular injection of normal saline

placebo

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Therapy Center

Amman, 11942, Jordan

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Abdalla Awidi, MD

    Cell Therapy Center

    STUDY DIRECTOR

Central Study Contacts

Sofia Adwan, Msc

CONTACT

00962796175617sophia.adwan@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Co-ordinator

Study Record Dates

First Submitted

August 8, 2017

First Posted

September 29, 2017

Study Start

April 18, 2018

Primary Completion

March 1, 2020

Study Completion

May 1, 2020

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

JO(1)