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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Kuala Lumpur, Malaisie, 56000
- Recrutement
- UKM Medical Centre
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Contact:
- Hanafiah Harunarashid, MD
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Chercheur principal:
- Hanafiah Harunarashid, MD
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Sous-enquêteur:
- Mohammad Azim Mohammad Idris, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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
Autres noms:
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Comparateur actif: Mononuclear cells only
Autologous bone marrow-derived mononuclear cells
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Intramuscular administration into the ischemic limb
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in angiogenesis
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Score analogique visuel
Délai: 1 mois, 3 mois, 6 mois, 9 mois, 12 mois
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1 mois, 3 mois, 6 mois, 9 mois, 12 mois
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Change in ulcer size
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Hanafiah Harunarashid, MD, UKM Medical Centre
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FF-113-2011
- NMRR-11-904-9763 (Identificateur de registre: National Medical Research Register)
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