Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease
NCT ID: NCT05854641
Last Updated: 2025-09-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-01-01
Study Completion Date
2027-12-31
Brief Summary
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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 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?
* Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial 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.
* Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes?
* Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial 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.
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Detailed Description
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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 Peripheral Arterial 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 peripheral arterial 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: 10 patients
Data Analysis
Data Management:
* Electronic case record form (eCRF) will be used for data entry.
* Oracle clinical (or other suitable alternatives with audit trail) will be used for data management.
Statistical Method:
* The SPSS® package (IBM Inc., USA, version 22) will be used for statistical evaluation.
* All patients in the study with relevant efficacy and safety data will be considered for the analysis.
* Efficacy analysis will be done using GEE (Generalized Estimating Equations) method or paired t test as appropriate.
* Adverse events monitored using information voluntarily disclosed by the patients and as observed by the PI will be summarized descriptively by total number of AE(s).
* AEs will be categorized as: all AEs, all treatment-emergent AEs, all severe AEs, treatment-related AEs and severe treatment-related AEs. These events will be reported as appropriate and summarized.
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 peripheral arterial 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: 10 patients
Data Analysis
Data Management:
* Electronic case record form (eCRF) will be used for data entry.
* Oracle clinical (or other suitable alternatives with audit trail) will be used for data management.
Statistical Method:
* The SPSS® package (IBM Inc., USA, version 22) will be used for statistical evaluation.
* All patients in the study with relevant efficacy and safety data will be considered for the analysis.
* Efficacy analysis will be done using GEE (Generalized Estimating Equations) method or paired t test as appropriate.
* Adverse events monitored using information voluntarily disclosed by the patients and as observed by the PI will be summarized descriptively by total number of AE(s).
* AEs will be categorized as: all AEs, all treatment-emergent AEs, all severe AEs, treatment-related AEs and severe treatment-related AEs. These events will be reported as appropriate and summarized.
Conditions
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Critical Limb Ischemia
Peripheral Arterial Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Stempeucel®
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 (Refer section 6.6 IMP Preparation and Designation). The final concentration of components will be 1.5% HSA and 3% DMSO.
Group Type
EXPERIMENTAL
Stempeucel®
Intervention Type
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).
Interventions
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Stempeucel®
• 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).
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion 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 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
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Stempeutics Research Pvt Ltd
INDUSTRY
Sponsor Role
collaborator
National University of Malaysia
OTHER
Sponsor Role
collaborator
Cell Biopeutics Resources Sdn Bhd
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hanafiah Harunarashid, MS
Role: PRINCIPAL_INVESTIGATOR
National University of Malaysia
Locations
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Hospital Canselor Tunku Mukhriz
Kuala Lumpur, , Malaysia
Site Status
RECRUITING
Countries
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Malaysia
Central Contacts
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Facility Contacts
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References
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ICH Topic E 2 A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting-(CPMP/ICH/377/95)
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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.
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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
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CBR-PAD-22-004
Identifier Type: -
Identifier Source: org_study_id
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UNKNOWN
PHASE1/PHASE2
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
NCT04848220
TERMINATED
PHASE2
Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
NCT00059644
TERMINATED
PHASE3
Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease
NCT01983449
COMPLETED
PHASE4
A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)
NCT05618691
WITHDRAWN
PHASE2
The Changes in Carotid Plaque Neovascularization After Elovocumab Therapy
NCT04423406
UNKNOWN
Cysteinyl Leukotriene Antagonist in Atherosclerosis Inhibition in Patients After Endovascular Treatment Due to Peripheral Arterial Disease
NCT04277702
UNKNOWN
PHASE3
Model System for Transient Forearm Blood Vessel Dysfunction
NCT00453531
COMPLETED
PHASE1/PHASE2
Evaluation of Cilostazol in Combination With L-Carnitine
NCT00822172
COMPLETED
PHASE4
SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
NCT02544204
UNKNOWN
PHASE2
The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM
NCT03174522
TERMINATED
PHASE3
Study of Intracoronary CD34+ Cell Administration in Patients With Early Coronary Atherosclerosis
NCT03471611
COMPLETED
PHASE1
Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
NCT03004638
COMPLETED
PHASE2
Angiogenesis and Blood Perfusion Effect of HGF Gene Therapy in PAD Patients
NCT05968118
UNKNOWN
PHASE3
Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension
NCT03254446
UNKNOWN
PHASE3
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
NCT01609140
COMPLETED
PHASE2
Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease
NCT00797056
COMPLETED
EARLY_PHASE1
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
NCT03469349
COMPLETED
PHASE3
FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease
NCT00424866
UNKNOWN
PHASE1/PHASE2
Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction
NCT04610892
COMPLETED
PHASE2