1. A prospective multicenter phase II study of intrabone marrow transplantation of unwashed cord blood using reduced-intensity conditioning
- Author
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Katsuji Kaida, Satoshi Yoshihara, Takashi Daimon, Shinichi Masuda, Yoshikazu Utsu, Hideho Wada, Takeshi Kobayashi, Hirotoshi Tokunaga, Hiroyasu Ogawa, Taizo Tasaka, Kazuhiro Ikegame, Yuho Najima, Masaya Okada, Yoshiko Matsuhashi, and Nobuyuki Aotsuka
- Subjects
Adult ,Male ,medicine.medical_specialty ,Time Factors ,Transplantation Conditioning ,Platelet Engraftment ,Graft vs Host Disease ,Phases of clinical research ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Recurrence ,Cause of Death ,Internal medicine ,Clinical endpoint ,Humans ,Medicine ,Local anesthesia ,Cumulative incidence ,Survival rate ,Aged ,Bone Marrow Transplantation ,business.industry ,Histocompatibility Testing ,Incidence ,Incidence (epidemiology) ,Graft Survival ,Hematology ,General Medicine ,Middle Aged ,Tissue Donors ,Blood Cell Count ,Surgery ,Survival Rate ,Treatment Outcome ,surgical procedures, operative ,Hematologic Neoplasms ,030220 oncology & carcinogenesis ,Cord blood ,Female ,Cord Blood Stem Cell Transplantation ,business ,030215 immunology - Abstract
Cord blood transplantation (CBT) is associated with delayed hematopoietic recovery and graft failure. To overcome these problems, we conducted a prospective, multicenter phase II study of intrabone marrow transplantation in which patients received reduced-intensity conditioning without anti-thymocyte globulin (ATG). The primary endpoint was the probability of full donor engraftment. Forty patients with hematologic malignancies were enrolled. Cord blood (CB) cells were injected without washing into 4 iliac bone sites (2 at each hemipelvis), at which approximately 6 mL of CB was administered at one site with local anesthesia. Full donor engraftment rate was 86.8%. The cumulative incidence of neutrophil and platelet engraftment was 86.4% and 85.5%, respectively. The median time to neutrophil (>0.5 × 109 /L) and platelet (2.0 × 109 /L) recovery was 17.5 and 44 days, respectively. The probability of severe acute graft-vs-host disease (GVHD) was 47.5%. The cumulative incidence of extensive chronic GVHD was 3.0%. The probability of relapse and non-relapse mortality was 30.4% and 28.0%, respectively. The survival rate at 3 years was 45.6%, although most patients were at an advanced stage. These results suggest that our intrabone marrow-CBT procedure without using ATG improves hematopoietic recovery and decreases the incidence of chronic GVHD, but does not decrease the incidence of acute GVHD.
- Published
- 2018