- ICH GCP
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- Essai clinique NCT00955669
Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
Comparison of Autologous Transplantation of Bone Marrow Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
Objective:
To compare the effect and safety of autologous transplantation of bone marrow mesenchymal stem cells(MSCs) and mononuclear cells(MNCs) on Diabetic patients with Critical Limb Ischemia and Foot Ulcer.
Methods:
patients were randomized into the A group and the B group by use of a randomization table. One lower limb in A group or in B group was selected randomly for MSCs or MNCs transplantation as MSCs or MNCs group, the other lower limb in the same patient was selected for placebo(normal saline ,NS)injection as NS group.
The whole procedures of this clinical trial were blinded to both patients and investigators.Patients in both groups received the same ordinary treatment. Meanwhile, MSCs and MNCs were transplanted into the impaired lower limbs respectively. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,Transcutaneous oxygen pressure,magnetic resonance angiography) and safety (infection of the injection site, immunological rejection, and tumour generation).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
RESEARCH DESIGN AND METHODS Written informed consent was obtained from all subjects. Type 2 diabetic patients with bilateral critical limb ischemia (ankle-brachial index, ABI from 0.30 to 0.60) and at least with one foot ulcer, but without malignant tumor or gangrene above the ankle and/or severe coronary, cerebral and renal vascular disease, were eligible for the participation in this trial. Eligible patients took part in this study on a voluntary basis. They were randomized into the A and B group by use of a randomization table. One lower limb in A group or in B group was selected randomly for BMMSCs or BMMNCs transplantation as BMMSCs or BMMNCs group, the other lower limb in the same patient was selected for placebo(normal saline ,NS)injection as NS group. The whole procedures of this clinical trial were blinded to both patients and investigators.
Preparation of Human Autologous Serum Preparation of MSCs and MNCs Flow Cytometric Analysis Examination of cells Safety Administration of therapy 5.0*108~5.0*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection.
observation index and assessment guidelines Statistical analysis
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Chongqing
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Chongqing, Chongqing, Chine, 400038
- the southwest Hospital
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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:
- Age from 40 to 70 years
- Type 2 diabetic patients
- bilateral critical limb ischemia(ABI from 0.30 to 0.60)
- at least with one foot ulcer
Exclusion Criteria:
- dry gangrene above the ankle or moist gangrene
- malignant tumor
- severe coronary,cerebral and renal vascular disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Symptoms and Objective Examination
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5.0*108~5.0*109
MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Magnetic resonance angiography
Délai: 24 weeks
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24 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Chen bing, doctor, Endocrinology and Metabolism Department, the south west Hospital of the Third Military Medical University
Publications et liens utiles
Publications générales
- Lu D, Jiang Y, Deng W, Zhang Y, Liang Z, Wu Q, Jiang X, Zhang L, Gao F, Cao Y, Chen B, Xue Y. Long-Term Outcomes of BMMSC Compared with BMMNC for Treatment of Critical Limb Ischemia and Foot Ulcer in Patients with Diabetes. Cell Transplant. 2019 May;28(5):645-652. doi: 10.1177/0963689719835177. Epub 2019 Mar 27.
- Chen Y, Ma Y, Li N, Wang H, Chen B, Liang Z, Ren R, Lu D, Boey J, Armstrong DG, Deng W. Efficacy and long-term longitudinal follow-up of bone marrow mesenchymal cell transplantation therapy in a diabetic patient with recurrent lower limb bullosis diabeticorum. Stem Cell Res Ther. 2018 Apr 10;9(1):99. doi: 10.1186/s13287-018-0854-9.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies de la peau
- Maladies du système endocrinien
- Angiopathies diabétiques
- Ulcère de jambe
- Ulcère de la peau
- Complications du diabète
- Diabète sucré
- Neuropathies diabétiques
- Maladies du pied
- Pied diabétique
- Ulcère du pied
- Ischémie
Autres numéros d'identification d'étude
- ldb2008101
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