Critical Limb IschemiaPhase 4NCT05854615
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
A Phase 4 study testing Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells in people with Critical Limb Ischemia and Buerger's Disease, run by Cell Biopeutics Resources Sdn Bhd at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Critical Limb Ischemia, Buerger's Disease
- What is being tested?
- Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2024to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years.
- Buerger's disease as diagnosed by Shionoya criteria
- Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm2 (both inclusive)
- 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
- 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
Who cannot join
- Patients diagnosed with atherosclerotic peripheral arterial disease
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Canselor Tunku Mukhriz
Kuala Lumpur, 56000
Farhana Raduan, MS, +603-9145 ext. 8299, farhana@ppukm.ukm.edu.my
Hanafiah Harunarashid, MS
About this study
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.
Read the detailed description
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:
- 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
- Critical Limb Ischemia, Buerger's Disease
- Being tested
- Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells
- Keywords
- critical limb ischemia, Buerger's disease, bone marrow derived mesenchymal stem cell
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Thromboangiitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cellsBiological
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ischemic rest pain
Change in visual analog score (VAS) compared to screening
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Screening (Day -14 to -1), Day 180
Secondary outcomes (8)
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
Measured: Screening (Day -14 to -1)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Screening (Day -14 to -1), Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Jan 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cell Biopeutics Resources Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stempeutics Research Pvt Ltd, National University of Malaysia
- Responsible party
- Sponsor
- Investigators
- Hanafiah Harunarashid, MS, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854615
- Sponsor's protocol ID
- CBR-BD-22-003
- Status last verified
- Sep 2025
- First submitted
- 30 Mar 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18048472Sprengers 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.
PubMed 18376183Dormandy J, Heeck L, Vig S. The fate of patients with critical leg ischemia. Semin Vasc Surg. 1999 Jun;12(2):142-7.
PubMed 10777241Gottsater A. Managing risk factors for atherosclerosis in critical limb ischaemia. Eur J Vasc Endovasc Surg. 2006 Nov;32(5):478-83. doi: 10.1016/j.ejvs.2006.03.007. Epub 2006 Apr 24.
PubMed 16631394Schiavetta A, Maione C, Botti C, Marino G, Lillo S, Garrone A, Lanza L, Pagliari S, Silvestroni A, Signoriello G, Sica V, Cobellis G. A 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. Stem Cells Transl Med. 2012 Jul;1(7):572-8. doi: 10.5966/sctm.2012-0021. Epub 2012 Jul 6.
PubMed 23197862Fadini GP, Agostini C, Avogaro A. Autologous stem cell therapy for peripheral arterial disease meta-analysis and systematic review of the literature. Atherosclerosis. 2010 Mar;209(1):10-7. doi: 10.1016/j.atherosclerosis.2009.08.033. Epub 2009 Aug 21.
PubMed 19740466Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.
PubMed 19897335Marston WA, Davies SW, Armstrong B, Farber MA, Mendes RC, Fulton JJ, Keagy BA. Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization. J Vasc Surg. 2006 Jul;44(1):108-114. doi: 10.1016/j.jvs.2006.03.026.
PubMed 16828434Gupta NK, Armstrong EJ, Parikh SA. The current state of stem cell therapy for peripheral artery disease. Curr Cardiol Rep. 2014 Feb;16(2):447. doi: 10.1007/s11886-013-0447-2.
PubMed 24414120Tachi Y, Fukui D, Wada Y, Koshikawa M, Shimodaira S, Ikeda U, Amano J. Changes in angiogenesis-related factors in serum following autologous bone marrow cell implantation for severe limb ischemia. Expert Opin Biol Ther. 2008 Jun;8(6):705-12. doi: 10.1517/14712598.8.6.705.
PubMed 18476781Amann B, Luedemann C, Ratei R, Schmidt-Lucke JA. Autologous bone marrow cell transplantation increases leg perfusion and reduces amputations in patients with advanced critical limb ischemia due to peripheral artery disease. Cell Transplant. 2009;18(3):371-80. doi: 10.3727/096368909788534942. Epub 2009 Apr 2.
PubMed 19500466Molavi B, Zafarghandi MR, Aminizadeh E, Hosseini SE, Mirzayi H, Arab L, Baharvand H, Aghdami N. Safety and Efficacy of Repeated Bone Marrow Mononuclear Cell Therapy in Patients with Critical Limb Ischemia in a Pilot Randomized Controlled Trial. Arch Iran Med. 2016 Jun;19(6):388-96.
PubMed 27293053Liang TW, Jester A, Motaganahalli RL, Wilson MG, G'Sell P, Akingba GA, Fajardo A, Murphy MP. Autologous bone marrow mononuclear cell therapy for critical limb ischemia is effective and durable. J Vasc Surg. 2016 Jun;63(6):1541-5. doi: 10.1016/j.jvs.2016.01.022. Epub 2016 Mar 23.
PubMed 27021379Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
PubMed 17140820Lawall H, Bramlage P, Amann B. Stem cell and progenitor cell therapy in peripheral artery disease. A critical appraisal. Thromb Haemost. 2010 Apr;103(4):696-709. doi: 10.1160/TH09-10-0688. Epub 2010 Feb 19.
PubMed 20174766
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05854615
- Acronym / sponsor ID
- CBR-BD-22-003
- Conditions
- Critical Limb Ischemia, Buerger's Disease
- Keywords
- critical limb ischemia, Buerger's disease, bone marrow derived mesenchymal stem cell
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Cell Biopeutics Resources Sdn BhdIndustry (pharma, biotech, devices)
- Collaborators
- Stempeutics Research Pvt Ltd, National University of Malaysia
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stempeucel® | Experimental | Biological: Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cellsStempeucel® (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 years.
- Buerger's disease as diagnosed by Shionoya criteria
- Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm2 (both inclusive)
- 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
- 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
Key exclusion criteria (4 listed)
- Patients diagnosed with atherosclerotic peripheral arterial disease
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cellsAlso: 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). | Biological | Stempeucel® |
Primary outcome
Change in ischemic rest pain
Time frame: Screening (Day -14 to -1), Day 30, 90, 180 and 360
Change in visual analog score (VAS) compared to screening
Change in size of the ulcer
Time frame: Screening (Day -14 to -1), Day 30, 90, 180 and 360
Change in size of the ulcer compared to screening
Change in ankle brachial pressure index (ABPI)
Time frame: Screening (Day -14 to -1), Day 30, 90, 180 and 360
Change in ankle brachial pressure index (ABPI) compared to screening
Change in total walking distance
Time frame: Screening (Day -14 to -1), Day 30, 90, 180 and 360
Change in total walking distance on a treadmill compared to screening
Change in major amputation-free survival
Time frame: Screening (Day -14 to -1), Day 30, 90, 180 and 360
Change in amputation-free survival compared to screening
Change in angiogenesis
Time frame: Screening (Day -14 to -1), Day 180
Change in angiogenesis measured by digital subtraction angiogram (DSA) compared to screening
8 secondary outcomes
The type of AE(s), number of AE(s) and proportion of patients with AE(s)
Time frame: Screening (Day -14 to -1)
Incidence of abnormal laboratory test results (serum chemistry, haematology, liver function test)
Time frame: Screening (Day -14 to -1), Day 7, 30, 90, 180 and 360
Incidence of abnormal urine test results
Time frame: Screening (Day -14 to -1), Day 180
Incidence of abnormal TNF-α
Time frame: Screening (Day -14 to -1), Day 7 and 30
Incidence of abnormal vital signs
Time frame: Screening (Day -14 to -1), Baseline, Day 7, 30, 90, 180 and 360
Incidence of abnormal physical examination
Time frame: Screening (Day -14 to -1), Baseline, Day 7, 30, 90, 180 and 360
Incidence of abnormal ECG parameters
Time frame: Screening (Day -14 to -1), Baseline, Day 7, 30, 90, 180 and 360
Incidence of abnormal chest condition
Time frame: Screening (Day -14 to -1), Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 18048472Haugen 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.
- Background: PubMed 18376183Sprengers 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.
- Background: PubMed 10777241Dormandy J, Heeck L, Vig S. The fate of patients with critical leg ischemia. Semin Vasc Surg. 1999 Jun;12(2):142-7.
- Background: PubMed 16631394Gottsater A. Managing risk factors for atherosclerosis in critical limb ischaemia. Eur J Vasc Endovasc Surg. 2006 Nov;32(5):478-83. doi: 10.1016/j.ejvs.2006.03.007. Epub 2006 Apr 24.
- Background: PubMed 23197862Schiavetta A, Maione C, Botti C, Marino G, Lillo S, Garrone A, Lanza L, Pagliari S, Silvestroni A, Signoriello G, Sica V, Cobellis G. A 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. Stem Cells Transl Med. 2012 Jul;1(7):572-8. doi: 10.5966/sctm.2012-0021. Epub 2012 Jul 6.
- Background: PubMed 19740466Fadini GP, Agostini C, Avogaro A. Autologous stem cell therapy for peripheral arterial disease meta-analysis and systematic review of the literature. Atherosclerosis. 2010 Mar;209(1):10-7. doi: 10.1016/j.atherosclerosis.2009.08.033. Epub 2009 Aug 21.
- Background: PubMed 19897335Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.
- Background: PubMed 16828434Marston WA, Davies SW, Armstrong B, Farber MA, Mendes RC, Fulton JJ, Keagy BA. Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization. J Vasc Surg. 2006 Jul;44(1):108-114. doi: 10.1016/j.jvs.2006.03.026.
- Background: PubMed 24414120Gupta NK, Armstrong EJ, Parikh SA. The current state of stem cell therapy for peripheral artery disease. Curr Cardiol Rep. 2014 Feb;16(2):447. doi: 10.1007/s11886-013-0447-2.
- Background: PubMed 18476781Tachi Y, Fukui D, Wada Y, Koshikawa M, Shimodaira S, Ikeda U, Amano J. Changes in angiogenesis-related factors in serum following autologous bone marrow cell implantation for severe limb ischemia. Expert Opin Biol Ther. 2008 Jun;8(6):705-12. doi: 10.1517/14712598.8.6.705.
- Background: PubMed 19500466Amann B, Luedemann C, Ratei R, Schmidt-Lucke JA. Autologous bone marrow cell transplantation increases leg perfusion and reduces amputations in patients with advanced critical limb ischemia due to peripheral artery disease. Cell Transplant. 2009;18(3):371-80. doi: 10.3727/096368909788534942. Epub 2009 Apr 2.
- Background: PubMed 27293053Molavi B, Zafarghandi MR, Aminizadeh E, Hosseini SE, Mirzayi H, Arab L, Baharvand H, Aghdami N. Safety and Efficacy of Repeated Bone Marrow Mononuclear Cell Therapy in Patients with Critical Limb Ischemia in a Pilot Randomized Controlled Trial. Arch Iran Med. 2016 Jun;19(6):388-96.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanafiah Harunarashid, MS principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adult human bone marrow derived, cultured, pooled, allogeneic mesenchymal stromal cells in people with Critical Limb Ischemia and Buerger's Disease, run by Cell Biopeutics Resources Sdn Bhd at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jezamine Lim, PhD (+60176073103, info@cellbiopeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ischemic rest pain (time frame: Screening (Day -14 to -1), Day 30, 90, 180 and 360). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854615, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.