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
Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia
Sponsors
Source
National University of Malaysia
Oversight Info
Has Dmc
No
Brief 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. 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.
Overall Status
Unknown status
Start Date
2011-03-01
Completion Date
2016-02-01
Primary Completion Date
2015-12-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change in angiogenesis |
1 month, 3 months, 6 months, 9 months, 12 months |
Secondary Outcome
Measure |
Time Frame |
|
Change in ulcer size |
1 month, 3 months, 6 months, 9 months, 12 months |
|
Visual Analog Score |
1 month, 3 months, 6 months, 9 months, 12 months |
|
Exercise Treadmill Test |
1 month, 3 months, 6 months, 9 months, 12 months |
|
Improvement in vascularity and blood supply |
1 month, 3 months, 6 months, 9 months and 12 months |
Enrollment
50
Condition
Intervention
Intervention Type
Biological
Intervention Name
Description
Intramuscular administration into the ischemic limb
Arm Group Label
Mononuclear and mesenchymal stem cells
Other Name
BM-MNC and BM-MSC
Intervention Type
Biological
Intervention Name
Description
Intramuscular administration into the ischemic limb
Arm Group Label
Mononuclear cells only
Other Name
BM-MNC
Eligibility
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Gender
All
Minimum Age
20 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Hanafiah Harunarashid, MD |
Principal Investigator |
UKM Medical Centre |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
UKM Medical Centre Kuala Lumpur 56000 Malaysia |
Recruiting |
Last Name: Hanafiah Harunarashid, MD |
Last Name: Hanafiah Harunarashid, MD Role: Principal Investigator Last Name: Mohammad Azim Mohammad Idris, MD Role: Sub-Investigator |
Location Countries
Country
Malaysia
Verification Date
2015-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
National University of Malaysia
Investigator Full Name
Dr Hanafiah Harunarashid
Investigator Title
Senior Consultant Vascular Surgeon
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
NMRR-11-904-9763
Number Of Arms
2
Arm Group
Arm Group Label
Mononuclear and mesenchymal stem cells
Arm Group Type
Experimental
Description
Autologous bone marrow-derived mononuclear cells and mesenchymal stem cells
Arm Group Label
Mononuclear cells only
Arm Group Type
Active Comparator
Description
Autologous bone marrow-derived mononuclear cells
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
October 4, 2011
Study First Submitted Qc
October 19, 2011
Study First Posted
October 21, 2011
Last Update Submitted
April 9, 2015
Last Update Submitted Qc
April 9, 2015
Last Update Posted
April 10, 2015
Last Known Status
Recruiting
ClinicalTrials.gov processed this data on August 31, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.