Peripheral Arterial DiseasePhase 1/2NCT03297814
Use of Allogenic Platelet Lysate in Peripheral Arterial Disease (PAD)
A Phase 1/2 study testing Platelet lysate in people with Peripheral Arterial Disease, run by Sophia Al-Adwan at 1 site in Jordan.
Trial summary
Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (PAD) Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Platelet lysate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- 18 Apr 2018to May 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Cell Therapy Center
Amman, 11942
Sofia Adwan, PhD, 962-6-5355000 ext. 23960, sophia.adwan@gmail.com
hanan Jafar, PhD, 00962-6-5355000 ext. 23960, hanan.jafar@gmail.com
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Trial, Investigating the Effect of Intramuscular Injection of Allogenic Platelet Lysate for the Treatment of PAD
Allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (PAD)
Read the 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
- Conditions
- Peripheral Arterial Disease
- Being tested
- Platelet lysate, Placebo
- Keywords
- Peripheral arterial disease, Platelet lysate
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet lysateBiological
Intramuscular injection of platelet lysate
PlaceboBiological
intramuscular injection of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Platelet lysate | Active comparator | A total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval Receives: 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 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI
Positive changes in patients' Ankle brachial index (ABI)
Measured: 12 months
Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure
Positive changes in patients' Toe pressure (mm Hg)
Measured: 12 months
Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2
Positive changes in patients' Transcutaneous oxygen pressure (TcPO2)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start18 Apr 2018
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophia Al-Adwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sophia Al-Adwan, University of Jordan
- Investigators
- Abdalla Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297814
- Sponsor's protocol ID
- PAD2UJCTC
- Status last verified
- Jul 2019
- First submitted
- 8 Aug 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Trial, Investigating the Effect of Intramuscular Injection of Allogenic Platelet Lysate for the Treatment of PAD
- ClinicalTrials.gov ID
- NCT03297814
- Acronym / sponsor ID
- PAD2UJCTC
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral arterial disease, Platelet lysate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sophia Al-AdwanUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet lysate | Active comparator | Biological: Platelet lysateA total of 5 ml platelet lysate will be intramuscularly injected in 4 doses with 2 week interval |
| placebo | Placebo comparator | Biological: PlaceboA total of 5 ml of Normal Saline will be intramuscularly injected in 4 doses with 2 week interval |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet lysateIntramuscular injection of platelet lysate | Biological | Platelet lysate |
| Placebointramuscular injection of normal saline | Biological | placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 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.
3 secondary outcomes
Evaluation of the preliminary efficacy of the platelet lysate injection on patients' ABI
Time frame: 12 months
Evaluation of the preliminary efficacy of the platelet lysate injection on patients' Toe pressure
Time frame: 12 months
Evaluation of the preliminary efficacy of the platelet lysate injection on patients' TcPO2
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdalla Awidi, MD study director
Cell Therapy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet lysate in people with Peripheral Arterial Disease, run by Sophia Al-Adwan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sofia Adwan, Msc (00962796175617, sophia.adwan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.