Critical Limb Ischemia Clinical Trial
Official title:
An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
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 Buerger's disease. The main questions it aims to answer are: - Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to Buerger's disease while improving the healing rate and functional outcomes? - Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to Buerger's disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.
Status | Recruiting |
Enrollment | 3 |
Est. completion date | December 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years. 2. Buerger's disease as diagnosed by Shionoya criteria 3. Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm2 (both inclusive) 4. Ankle Brachial Pressure Index (ABPI) = 0.6. If ABPI is = 1.1 then Toe Brachial Index (TBI) will be performed and TBI should be = 0.5 5. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits Exclusion Criteria: 1. Patients diagnosed with atherosclerotic peripheral arterial disease 2. Patients eligible for surgical or percutaneous revascularization 3. Patients with a history of participating in another stem cell trial or therapy within 3 months 4. Patients who are unsuitable to participate the clinical trial as determined by investigators |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Canselor Tunku Mukhriz | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
Cell Biopeutics Resources Sdn Bhd | National University of Malaysia, Stempeutics Research Pvt Ltd |
Malaysia,
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* Note: There are 46 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in ischemic rest pain | Change in visual analog score (VAS) compared to screening | Screening (Day -14 to -1), Day 30, 90, 180 and 360 | |
Primary | Change in size of the ulcer | Change in size of the ulcer compared to screening | Screening (Day -14 to -1), Day 30, 90, 180 and 360 | |
Primary | Change in ankle brachial pressure index (ABPI) | Change in ankle brachial pressure index (ABPI) compared to screening | Screening (Day -14 to -1), Day 30, 90, 180 and 360 | |
Primary | Change in total walking distance | Change in total walking distance on a treadmill compared to screening | Screening (Day -14 to -1), Day 30, 90, 180 and 360 | |
Primary | Change in major amputation-free survival | Change in amputation-free survival compared to screening | Screening (Day -14 to -1), Day 30, 90, 180 and 360 | |
Primary | Change in angiogenesis | Change in angiogenesis measured by digital subtraction angiogram (DSA) compared to screening | Screening (Day -14 to -1), Day 180 | |
Secondary | The type of AE(s), number of AE(s) and proportion of patients with AE(s) | AE(s) will be monitored and recorded as voluntarily disclosed by the patients and as observed by the investigator throughout the study | Screening (Day -14 to -1) | |
Secondary | Incidence of abnormal laboratory test results (serum chemistry, haematology, liver function test) | The following lab tests will be conducted: serum chemistry, haematology, liver function test. In case of abnormal results, they shall be recorded as an adverse event or excluded from study (screening). | Screening (Day -14 to -1), Day 7, 30, 90, 180 and 360 | |
Secondary | Incidence of abnormal urine test results | Urine test will be conducted. In case of abnormal results, they shall be recorded as an adverse event or excluded from study (screening). | Screening (Day -14 to -1), Day 180 | |
Secondary | Incidence of abnormal TNF-a | TNF-a test will be conducted. In case of abnormal results, they shall be recorded as an adverse event or excluded from study (screening). | Screening (Day -14 to -1), Day 7 and 30 | |
Secondary | Incidence of abnormal vital signs | The following assessments will be conducted: blood pressure, heart rate, respiratory rate and temperature. In case of abnormal results, they shall be recorded as an adverse event or excluded from study (screening). | Screening (Day -14 to -1), Baseline, Day 7, 30, 90, 180 and 360 | |
Secondary | Incidence of abnormal physical examination | The following examinations will be conducted: visual, heart, lungs, abdomen, nervous system, muscoskeletal system and etc. In case of abnormal conditions, they shall be recorded as an adverse event or excluded from study (screening). | Screening (Day -14 to -1), Baseline, Day 7, 30, 90, 180 and 360 | |
Secondary | Incidence of abnormal ECG parameters | The following assessments will be conducted: 12 lead ECG recordings with long Lead II, and two-dimensional echocardiography (2D ECHO; if needed). In case of abnormal conditions, they shall be recorded as an adverse event or excluded from study (screening). | Screening (Day -14 to -1), Baseline, Day 7, 30, 90, 180 and 360 | |
Secondary | Incidence of abnormal chest condition | Chest x-ray will be conducted. In case of abnormal conditions, they shall be recorded as an adverse event or excluded from study (screening). | Screening (Day -14 to -1), Day 180 |
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