Critical Limb IschemiaPhase 2NCT01456819
Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia
A Phase 2 study testing Mononuclear and mesenchymal stem cells and Mononuclear cells in people with Critical Limb Ischemia, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow mononuclear cells implantation only in patients with chronic critical limb ischemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Mononuclear and mesenchymal stem cells and Mononuclear cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- Mar 2011to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of critical limb ischemia leading to ischemic ulcers in which amputation is indicated
- Not suitable for, or remain symptomatic despite angioplasty, bypass operation or collateralization
Who cannot join
- Contraindication to epidural anesthesia and bone marrow aspiration
- Contraindication to contrast angiography
- Evidence of neoplasia and bone marrow diseases
- Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Patients with a limited life expectancy (< 1 year)
- Patients with myocardial infarction or stroke within 6 months
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- Patients with coronary intervention within 6 months
- Renal impairment indicated by serum creatinine greater than two times upper limit of the normal range
- Liver impairment indicated by serum aspartate transaminase and alanine transaminase greater than two times upper limit of normal
- Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
UKM Medical Centre
Kuala Lumpur, 56000
Hanafiah Harunarashid, MD
Hanafiah Harunarashid, MD
About this study
Official title: Phase II Efficacy Study of Intramuscular Autologous Bone Marrow Mononuclear Cells Plus Mesenchymal Stem Cell Implantation Versus Autologous Bone Marrow Mononuclear Cells Implantation Only in Patients With Chronic Critical Limb Ischemia
This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow mononuclear cells implantation only in patients with chronic critical limb ischemia. Patients will be randomized into two groups of equal number; patients in one group will be implanted with mononuclear cells and mesenchymal stem cells, and the other implanted with mononuclear cells only in the area of affected limb.
Read the detailed description
When the long blood vessels supplying blood to the arms and legs become blocked (ischemic), patient will experience painful sensations in their calves when they walked which slowly become excruciating painful at rest. When the condition worsens, the patients will not be able to feel any pain from their legs and they will not know if there are any small ulcers or cuts on their legs. As a result, a small ulcer which goes unnoticed becomes bigger and can sometimes become infected. In the worst situations, infection might lead towards gangrene and septicaemia. Severe rest pain and/or ulcerations of ischemic limbs are defined as the state of chronic critical limb ischemia and at this point, amputation of the affected limb is suggested.
Conventional treatments include angioplasty/bypass operation to remove blood vessel blockage to restore blood supply, the use of prescribed medicines to aid in ulcer recovery and clear infection and debridement of damaged/infected tissue. Some procedures have to be performed multiple times. Amputation is inevitable in many cases because some blood capillaries cannot be corrected and restenosis of vessels is very common. Cell therapy with mononuclear cells and mesenchymal stem cells from bone marrow is promising because these stem cells are capable of stimulating and regenerating capillaries and blood vessels.
- Conditions
- Critical Limb Ischemia
- Being tested
- Mononuclear and mesenchymal stem cells, Mononuclear cells
- Keywords
- autologous, bone marrow, critical limb ischemia, efficacy, mesenchymal stem cells, mononuclear cells
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mononuclear and mesenchymal stem cellsBiological
Also called BM-MNC and BM-MSC
Intramuscular administration into the ischemic limb
Mononuclear cellsBiological
Also called BM-MNC
Intramuscular administration into the ischemic limb
| Study group | Role | What they receive |
|---|---|---|
| Mononuclear and mesenchymal stem cells | Experimental | Autologous bone marrow-derived mononuclear cells and mesenchymal stem cells Receives: Biological: Mononuclear and mesenchymal stem cells |
| Mononuclear cells only | Active comparator | Autologous bone marrow-derived mononuclear cells Receives: Biological: Mononuclear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in angiogenesis
Measurement of angiogenesis by presence of peripheral pulses, capillary refill and transcutaneous oxygen saturation (TCOS).
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
Secondary outcomes (4)
Change in ulcer size
Measurement of ulcer size by clinical assessment and grid maps.
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
Visual Analog Score
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
Exercise Treadmill Test
Measured: 1 month, 3 months, 6 months, 9 months, 12 months
Improvement in vascularity and blood supply
Measured by digital subtraction angiography (DSA) and ankle brachial systemic pressure index (ABI).
Measured: 1 month, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Cytopeutics Sdn. Bhd.
- Responsible party
- Principal investigator, Dr Hanafiah Harunarashid, National University of Malaysia
- Investigators
- Hanafiah Harunarashid, MD, Principal investigator, UKM Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456819
- Sponsor's protocol ID
- FF-113-2011
- Other IDs
- NMRR-11-904-9763
- Status last verified
- Apr 2015
- First submitted
- 4 Oct 2011
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Efficacy Study of Intramuscular Autologous Bone Marrow Mononuclear Cells Plus Mesenchymal Stem Cell Implantation Versus Autologous Bone Marrow Mononuclear Cells Implantation Only in Patients With Chronic Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT01456819
- Acronym / sponsor ID
- FF-113-2011
- Conditions
- Critical Limb Ischemia
- Keywords
- autologous, bone marrow, critical limb ischemia, efficacy, mesenchymal stem cells, mononuclear cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Cytopeutics Sdn. Bhd.
- Study start
- Mar 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 21 Oct 2011 (estimated)
- 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.
This is a randomized and single blinded study aimed to compare the efficacy between intramuscular autologous bone marrow mononuclear cells plus mesenchymal stem cell implantation and intramuscular autologous bone marrow mononuclear cells implantation only in patients with chronic critical limb ischemia. Patients will be randomized into two groups of equal number; patients in one group will be implanted with mononuclear cells and mesenchymal stem cells, and the other implanted with mononuclear cells only in the area of affected limb.
Detailed description
When the long blood vessels supplying blood to the arms and legs become blocked (ischemic), patient will experience painful sensations in their calves when they walked which slowly become excruciating painful at rest. When the condition worsens, the patients will not be able to feel any pain from their legs and they will not know if there are any small ulcers or cuts on their legs. As a result, a small ulcer which goes unnoticed becomes bigger and can sometimes become infected. In the worst situations, infection might lead towards gangrene and septicaemia. Severe rest pain and/or ulcerations of ischemic limbs are defined as the state of chronic critical limb ischemia and at this point, amputation of the affected limb is suggested.
Conventional treatments include angioplasty/bypass operation to remove blood vessel blockage to restore blood supply, the use of prescribed medicines to aid in ulcer recovery and clear infection and debridement of damaged/infected tissue. Some procedures have to be performed multiple times. Amputation is inevitable in many cases because some blood capillaries cannot be corrected and restenosis of vessels is very common. Cell therapy with mononuclear cells and mesenchymal stem cells from bone marrow is promising because these stem cells are capable of stimulating and regenerating capillaries and blood vessels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mononuclear and mesenchymal stem cells | Experimental | Biological: Mononuclear and mesenchymal stem cellsAutologous bone marrow-derived mononuclear cells and mesenchymal stem cells |
| Mononuclear cells only | Active comparator | Biological: Mononuclear cellsAutologous bone marrow-derived mononuclear cells |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of critical limb ischemia leading to ischemic ulcers in which amputation is indicated
- Not suitable for, or remain symptomatic despite angioplasty, bypass operation or collateralization
Key exclusion criteria (10 listed)
- Contraindication to epidural anesthesia and bone marrow aspiration
- Contraindication to contrast angiography
- Evidence of neoplasia and bone marrow diseases
- Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Patients with a limited life expectancy (< 1 year)
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 |
|---|---|---|
| Mononuclear and mesenchymal stem cellsAlso: BM-MNC and BM-MSCIntramuscular administration into the ischemic limb | Biological | Mononuclear and mesenchymal stem cells |
| Mononuclear cellsAlso: BM-MNCIntramuscular administration into the ischemic limb | Biological | Mononuclear cells only |
Primary outcome
Change in angiogenesis
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Measurement of angiogenesis by presence of peripheral pulses, capillary refill and transcutaneous oxygen saturation (TCOS).
4 secondary outcomes
Change in ulcer size
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Visual Analog Score
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Exercise Treadmill Test
Time frame: 1 month, 3 months, 6 months, 9 months, 12 months
Improvement in vascularity and blood supply
Time frame: 1 month, 3 months, 6 months, 9 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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. This study is not recruiting at the moment.
Hanafiah Harunarashid, MD principal investigator
UKM Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mononuclear and mesenchymal stem cells and Mononuclear cells in people with Critical Limb Ischemia, run by National University of Malaysia 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 10 Apr 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanafiah Harunarashid, MD (+60391456208, hanafiah@ppukm.ukm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in angiogenesis (time frame: 1 month, 3 months, 6 months, 9 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2015.