Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia

NCT ID: NCT01456819

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-02-29

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.

Conditions

Critical Limb Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mononuclear and mesenchymal stem cells

Autologous bone marrow-derived mononuclear cells and mesenchymal stem cells

Group Type: EXPERIMENTAL

Mononuclear and mesenchymal stem cells

Intervention Type: BIOLOGICAL

Intramuscular administration into the ischemic limb

Mononuclear cells only

Autologous bone marrow-derived mononuclear cells

Group Type: ACTIVE_COMPARATOR

Mononuclear cells

Intervention Type: BIOLOGICAL

Intramuscular administration into the ischemic limb

Interventions

Mononuclear and mesenchymal stem cells

Intramuscular administration into the ischemic limb

Intervention Type: BIOLOGICAL

Mononuclear cells

Intramuscular administration into the ischemic limb

Intervention Type: BIOLOGICAL

Other Intervention Names

BM-MNC and BM-MSC; 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytopeutics Sdn. Bhd.

INDUSTRY

Sponsor Role: collaborator

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Dr Hanafiah Harunarashid

Senior Consultant Vascular Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanafiah Harunarashid, MD

Role: PRINCIPAL_INVESTIGATOR

UKM Medical Centre

Locations

UKM Medical Centre

Kuala Lumpur, , Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Hanafiah Harunarashid, MD

Role: CONTACT

hanafiah@ppukm.ukm.my

+60391456208

Facility Contacts

Hanafiah Harunarashid, MD

Role: primary

Other Identifiers

NMRR-11-904-9763

Identifier Type: REGISTRY

Identifier Source: secondary_id

FF-113-2011

Identifier Type: -

Identifier Source: org_study_id