Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Kuala Lumpur, Maleisië, 56000
- Werving
- UKM Medical Centre
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Contact:
- Hanafiah Harunarashid, MD
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Hoofdonderzoeker:
- Hanafiah Harunarashid, MD
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Onderonderzoeker:
- Mohammad Azim Mohammad Idris, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Mononuclear and mesenchymal stem cells
Autologous bone marrow-derived mononuclear cells and mesenchymal stem cells
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Intramuscular administration into the ischemic limb
Andere namen:
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Actieve vergelijker: Mononuclear cells only
Autologous bone marrow-derived mononuclear cells
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Intramuscular administration into the ischemic limb
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in angiogenesis
Tijdsspanne: 1 month, 3 months, 6 months, 9 months, 12 months
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Measurement of angiogenesis by presence of peripheral pulses, capillary refill and transcutaneous oxygen saturation (TCOS).
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1 month, 3 months, 6 months, 9 months, 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Visuele analoge score
Tijdsspanne: 1 maand, 3 maanden, 6 maanden, 9 maanden, 12 maanden
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1 maand, 3 maanden, 6 maanden, 9 maanden, 12 maanden
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Change in ulcer size
Tijdsspanne: 1 month, 3 months, 6 months, 9 months, 12 months
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Measurement of ulcer size by clinical assessment and grid maps.
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1 month, 3 months, 6 months, 9 months, 12 months
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Exercise Treadmill Test
Tijdsspanne: 1 month, 3 months, 6 months, 9 months, 12 months
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1 month, 3 months, 6 months, 9 months, 12 months
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Improvement in vascularity and blood supply
Tijdsspanne: 1 month, 3 months, 6 months, 9 months and 12 months
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Measured by digital subtraction angiography (DSA) and ankle brachial systemic pressure index (ABI).
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1 month, 3 months, 6 months, 9 months and 12 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Hanafiah Harunarashid, MD, UKM Medical Centre
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FF-113-2011
- NMRR-11-904-9763 (Register-ID: National Medical Research Register)
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