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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
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Kuala Lumpur, Malaysia, 56000
- Rekrytering
- UKM Medical Centre
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Kontakt:
- Hanafiah Harunarashid, MD
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Huvudutredare:
- Hanafiah Harunarashid, MD
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Underutredare:
- Mohammad Azim Mohammad Idris, MD
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
Andra namn:
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Aktiv komparator: Mononuclear cells only
Autologous bone marrow-derived mononuclear cells
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Intramuscular administration into the ischemic limb
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in angiogenesis
Tidsram: 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).
|
1 month, 3 months, 6 months, 9 months, 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visuell analog poäng
Tidsram: 1 månad, 3 månader, 6 månader, 9 månader, 12 månader
|
1 månad, 3 månader, 6 månader, 9 månader, 12 månader
|
|
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Change in ulcer size
Tidsram: 1 month, 3 months, 6 months, 9 months, 12 months
|
Measurement of ulcer size by clinical assessment and grid maps.
|
1 month, 3 months, 6 months, 9 months, 12 months
|
|
Exercise Treadmill Test
Tidsram: 1 month, 3 months, 6 months, 9 months, 12 months
|
1 month, 3 months, 6 months, 9 months, 12 months
|
|
|
Improvement in vascularity and blood supply
Tidsram: 1 month, 3 months, 6 months, 9 months and 12 months
|
Measured by digital subtraction angiography (DSA) and ankle brachial systemic pressure index (ABI).
|
1 month, 3 months, 6 months, 9 months and 12 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Hanafiah Harunarashid, MD, UKM Medical Centre
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FF-113-2011
- NMRR-11-904-9763 (Registeridentifierare: National Medical Research Register)
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