BridgeMD
Tests treatment safety and results for Critical Limb Ischemia
Official title Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease
ClinicalTrials.gov ID: NCT05854641
What this study is testing
What is Stempeucel®?
Stempeucel® is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for critical limb ischemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral arterial disease. The main questions it aims to answer are: Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients between 18-65 years old
- Patients diagnosed with atherosclerotic peripheral arterial disease
- Patients not eligible for or have failed surgical or percutaneous revascularization (No option patients)
- Patients with at least one ulcer (between 0.5 to 10 cm2 size)
- Ankle brachial pressure index (ABPI) ≤ 0.6 (toe brachial index (TBI) if ABPI out of range; TBI ≤ 0.5)
You likely can't join if
- Patients diagnosed with Buerger's disease by Shionoya criteria
- Patients eligible for surgical or percutaneous revascularization
- Patients with a history of participating in another stem cell trial or therapy within 3 months
- Patients who are unsuitable to participate the clinical trial as determined by investigators
See the full eligibility criteria
- Patients between 18-65 years old
- Patients diagnosed with atherosclerotic peripheral arterial disease
- Patients not eligible for or have failed surgical or percutaneous revascularization (No option patients)
- Patients with at least one ulcer (between 0.5 to 10 cm2 size)
- Ankle brachial pressure index (ABPI) ≤ 0.6 (toe brachial index (TBI) if ABPI out of range; TBI ≤ 0.5)
- Patients who are able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations
- Patients diagnosed with Buerger's disease by Shionoya criteria
- Patients eligible for surgical or percutaneous revascularization
- Patients with a history of participating in another stem cell trial or therapy within 3 months
- Patients who are unsuitable to participate the clinical trial as determined by investigators
The study team makes the final eligibility decision.
Where it's taking place
- Kuala Lumpur, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kuala Lumpur, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.