Progenitor cell therapy in patients with critical limb ischemia without surgical options.
Ralf W Sprengers, Daniel J Lips, Frans L Moll...
https://pubmed.ncbi.nlm.nih.gov/18376183Actively Recruiting
Phase 4
Age: 18Years - 65Years
All Genders
ID05854641
Observational Feasibility Study of Intramuscular Stempeucel4 in Malaysian Patients With Critical Limb Ischemia Due to Peripheral Arterial Disease
Led by Cell Biopeutics Resources Sdn Bhd · Updated on 2025-09-09
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Cell Biopeutics Resources Sdn Bhd
Lead Sponsor
S
Stempeutics Research Pvt Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of intramuscular administration of Stempeucel4, a type of cultured mesenchymal stem cell treatment, in Malaysian patients with critical limb ischemia (CLI) caused by peripheral arterial disease. This observational, practice-based feasibility study aims to see if Stempeucel4 can reduce CLI symptoms, improve healing and functional outcomes, and determine if it causes any serious side effects. The study will follow patients for up to one year after treatment for safety and efficacy assessment. Participants will receive Stempeucel4, which consists of ex-vivo cultured allogeneic mesenchymal stem cells provided in cryo-bags containing 150 or 200 million cells suspended in Plasmalyte A solution. The dose is based on body weight at 2 million cells per kilogram. The treatment involves 40 to 60 intramuscular injections into different muscle points and additional injections around ulcers. The study includes about 10 patients and uses electronic data systems to collect and analyze safety and effectiveness data. During the study, patients will undergo assessments at screening and on days 30, 90, 180, and 360. These assessments include measuring pain levels at rest, ulcer size, ankle brachial pressure index, walking distance, amputation-free survival, and angiogenesis. Safety monitoring includes checking adverse events, laboratory tests, vital signs, physical exams, ECGs, and chest conditions. The total study duration is approximately 18 months, and data will be analyzed using statistical methods to evaluate outcomes.
CONDITIONS
Brief Title
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 65 years old
- Diagnosed with atherosclerotic peripheral arterial disease
- Not eligible for or have failed surgical or percutaneous revascularization
- Have at least one ulcer sized between 0.5 and 10 cm2
- Ankle brachial pressure index (ABPI) 60.6 or toe brachial index (TBI) 60.5 if ABPI is out of range
- Able and willing to provide consent and comply with study procedures and follow-up
You will not qualify if you...
- Diagnosed with Buerger's disease by Shionoya criteria
- Eligible for surgical or percutaneous revascularization
- Participated in another stem cell trial or therapy within the last 3 months
- Considered unsuitable for the clinical trial by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Single administration with follow-up up to 12 months
Participants receive intramuscular injections of Stempeucel®, an investigational stem cell therapy, administered into muscles and around ulcers.
Visits on Day 7, 30, 90, 180, and 360 for assessments
Follow-up
Duration - Up to 12 months after treatment
Participants are monitored for efficacy and safety outcomes including pain, ulcer size, blood flow, walking distance, and adverse events.
Visits on Day 7, 30, 90, 180, and 360 for ongoing assessments
Trial Site Locations
Total: 1 location
1
Hospital Canselor Tunku Mukhriz
Kuala Lumpur, Malaysia, 56000
Actively Recruiting
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Research Team
J
Jezamine Lim, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Risk assessment in the patient with established peripheral arterial disease.
Scott Haugen, Ivan P Casserly, Judith G Regensteiner...
https://pubmed.ncbi.nlm.nih.gov/18048472The fate of patients with critical leg ischemia.
J Dormandy, L Heeck, S Vig
https://pubmed.ncbi.nlm.nih.gov/10777241Managing risk factors for atherosclerosis in critical limb ischaemia.
A Gottsäter
https://pubmed.ncbi.nlm.nih.gov/16631394A phase II trial of autologous transplantation of bone marrow stem cells for critical limb ischemia: results of the Naples and Pietra Ligure Evaluation of Stem Cells study.
Alessandro Schiavetta, Ciro Maione, Chiara Botti...
https://pubmed.ncbi.nlm.nih.gov/23197862Autologous stem cell therapy for peripheral arterial disease meta-analysis and systematic review of the literature.
Gian Paolo Fadini, Carlo Agostini, Angelo Avogaro
https://pubmed.ncbi.nlm.nih.gov/19740466Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia.
Michael S Conte, Patrick J Geraghty, Andrew W Bradbury...
https://pubmed.ncbi.nlm.nih.gov/19897335Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization.
William A Marston, Stephen W Davies, Brian Armstrong...
https://pubmed.ncbi.nlm.nih.gov/16828434The current state of stem cell therapy for peripheral artery disease.
Nitin K Gupta, Ehrin J Armstrong, Sahil A Parikh
https://pubmed.ncbi.nlm.nih.gov/24414120Changes in angiogenesis-related factors in serum following autologous bone marrow cell implantation for severe limb ischemia.
Yoshihito Tachi, Daisuke Fukui, Yuko Wada...
https://pubmed.ncbi.nlm.nih.gov/18476781