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| Name | Class |
|---|---|
| Stempeutics Research Pvt Ltd | INDUSTRY |
| National University of Malaysia | OTHER |
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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:
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
Study Design: Single arm, practice-based, feasibility study
Study Duration: Estimated duration for the main protocol (e.g. from starts of screening to last subject processed and end of the study) is approximately 18 months
Study Center: Universiti Kebangsaan Malaysia Medical Centre (UKMMMC), Jalan Yaacob Latif, Bandar Tun Razak, 56000 Kuala Lumpur, Wilayah Persekutuan, Malaysia
Objectives: To observe the efficacy and safety of Stempeucel® (adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells) in Malaysian patients with critical limb ischemia (CLI) due to Buerger's disease.
Investigational Medicinal Product
Description
• Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in cryo-bags consisting of 150 or 200 million, suspended in 50 ml of Plasmalyte A containing 1.5% human serum albumin (HSA) and 3% dimethyl sulfoxide (DMSO).
Dosage • Dosing of Stempeucel® is based on body weight. The recommended dose is 2 million cells/kg body weight.
Administration
• 40 - 60 injections administered as 0.6 ml/kg (200 million bag) or 0.8 ml/kg (150 million bag) intramuscularly into different points on the muscle. Additional injections of 2 ml (200 million bag) or 3 ml (150 million bag) administered around the ulcer
Number of Subjects 3 patients
Data Analysis
Data Management:
Statistical Method:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stempeucel® | Experimental | Stempeucel® (Ex-vivo cultured MSCs) supplied in 15 ml cryo bags consisting of 200 million or 150 million MSCs, 85% PlasmaLyte-A, 5% HSA and 10% DMSO in a total volume of 15 ml. Following thawing, 35 ml of PlasmaLyte A will be added to the Stempeucel® to make a total volume of 50 ml. The final concentration of components will be 1.5% HSA and 3% DMSO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells | Biological | • Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in cryo-bags consisting of 150 or 200 million, suspended in 50 ml of Plasmalyte A containing 1.5% human serum albumin (HSA) and 3% dimethyl sulfoxide (DMSO). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in angiogenesis | Change in angiogenesis measured by digital subtraction angiogram (DSA) compared to screening | Screening (Day -14 to -1), Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Incidence of abnormal laboratory test results (serum chemistry, haematology, liver function test) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jezamine Lim, PhD | Contact | +60176073103 | info@cellbiopeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Hanafiah Harunarashid, MS | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Canselor Tunku Mukhriz | Recruiting | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18048472 | Background | Haugen S, Casserly IP, Regensteiner JG, Hiatt WR. Risk assessment in the patient with established peripheral arterial disease. Vasc Med. 2007 Nov;12(4):343-50. doi: 10.1177/1358863X07083278. | |
| 18376183 | Background | Sprengers RW, Lips DJ, Moll FL, Verhaar MC. Progenitor cell therapy in patients with critical limb ischemia without surgical options. Ann Surg. 2008 Mar;247(3):411-20. doi: 10.1097/SLA.0b013e318153fdcb. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2022 |
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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 |
| 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 |
| Incidence of abnormal TNF-α | TNF-α 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 |
| 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 |
| 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 |
| 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 |
| 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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| Background | ICH Topic E 2 A:Clinical Safety Data Management: Definitions and Standards for Expedited Reporting-(CPMP/ICH/377/95) |
| Background | Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India. Draft Guidelines on Audio-Visual Recording of Informed Consent Process in Clinical Trial. 2014. [cited 2016 Jul 29]. Available from: http://www.cdsco.nic.in/writereaddata/Guidance_for_AV%20Recording_09.January.14.pdf. |
| Background | ClinicalTrials.gov. Identifier NCT01257776, Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients. Available from: http://clinicaltrials.gov/ct2/show/NCT01079403 |
| Mar 28, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D013919 | Thromboangiitis Obliterans |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D014657 | Vasculitis |
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