Haematopoietic stem cell transplantation (HSCT) has been proposed for refractory autoimmune diseases, including systemic sclerosis (SSc) A sequential Bayesian phase I-II clinical trial was conducted in SSc patients to assess the feasibility, the tolerance and the efficacy of autologous HSCT Peripheral blood stem cells (PBSC) were collected using cyclophosphamide (4 g/m2) and recombinant human granulocyte colony-stimulating factor (5 micro g/kg/d) and reinfused after positive CD34+ selection Conditioning used cyclophosphamide (200 mg/kg) or melphalan (140 mg/m2) according to cardiac function The main end-point was the failure of the procedure, defined by failure of either PBSC mobilization, CD34+ selection or intensification procedure, or by procedure-related death Among the 12 enrolled patients, three failures occurred: one PBSC mobilization, one CD34+ selection and one CD34+ intensification Probability of graft failure was estimated at 0286 (95% confidence interval: 0095-054) Autologous PBSC (n = 10) or bone marrow (n = 1) transplantation was actually performed in 11 patients with one procedure-related death Median time to neutrophil (> 05 x 10(9)/l) and platelet (> 25 x 10(9)/l) haematopoietic reconstitution was 12 and 10 d respectively After 18 months (range 1-26), eight out of 11 patients have shown major or partial response Non-myeloablative conditioning, followed by a T cell-depleted autologous PBSC or bone marrow transplantation, appears feasible with low toxicity in severe SSc with short-term clinical benefits

https://onlinelibrary.wiley.com/doi/pdf/10.1046/j.1365-2141.2002.03895.x

Autologous bone marrow transplantation in the treatment of refractory systemic sclerosis: early results from a French multicentre phase I-II study.

Souza et al, Blood 66 1985 102(a). Sevier et al, Clin Chem 27/u, 1981, pp. 1797-1806. Kipps et al., Handbook of Experimental Immunol, ed Weir et al., 1986, pp. 108.1-108.9 Nature, vol. 319, Jan. 30, 1986, by S. Nagata, "Molecu lar Cloning and Expression of cDNA for Human Gran ulocyte Colony Stimulating Factor" pp. 415-418. Science, vol. 232, No. 4746 Apr. 4, 1986, by Souza et al, "Recombinant Human Granulocyte Colony-Stimulat ing Factor: Effects on Normal and Leukemic Myeloid Cells", pp. 61-65. Primary Examiner-Garnette D. Draper

Recombinant human granulocyte-colony stimulating factor의 토끼에 피부 및 안점막 자극 평가

Veno-occlusive disease of the liver after high-dose cytoreductive therapy with busulfan and melphalan for autologous blood stem cell transplantation in multiple myeloma patients.

Factors associated with peripheral blood stem cell yield in volunteer donors mobilized with granulocyte colony-stimulating factors: the impact of donor characteristics and procedural settings.

Use of recombinant human growth hormone (rhGH) plus recombinant human granulocyte colony-stimulating factor (rhG-CSF) for the mobilization and collection of CD34+ cells in poor mobilizers.

For 10 consecutive patients in our unit who did not show a significant rise in blood progenitor cells within 14 days following chemotherapy and G-CSF, we increased the G-CSF dose from 5 to 10 microg/kg/day (n = 9) or from 10 to 15 microg/kg/day (n = 1). As a result, there were significant increases in total yield as well as yield per apheresis of mononuclear cells, CD34+ cells and CFU-GM (P < 0.025, <0.01 and <0.005, respectively). After G-CSF dose escalation, six of the 10 patients had sufficient CD34+ cells for performing transplantation. These results demonstrate a dose-dependent response of progenitor cell mobilization by G-CSF when used in combination with chemotherapy. Moreover, increasing the dose of G-CSF as late as the third week of mobilization may still provide sufficient cell yield even with patients who did not show a significant mobilization with conventional doses of G-CSF.

Granulocyte colony-stimulating factor (G-CSF) dose-dependent efficacy in peripheral blood stem cell mobilization in patients who had failed initial mobilization with chemotherapy and G-CSF

Background: Even after high dose chemotherapy (HDT) and autologous haemopoietic stem cell transplantation, the majority of patients with multiple myeloma eventually relapse.



Aim:  The aim of the present study was to study the ­feasibility and outcome of delivering a regimen including in vivo and in vitro purging and double HDT in patients with multiple myeloma.



Methods:  Thirty-four patients with advanced multiple myeloma were enrolled in a program of vincristine, doxo­rubicin and dexamethasone chemotherapy, high dose cyclophosphamide/granulocyte macrophage colony stimulating factor (GM-CSF) stem cell mobilisation, CD34 selection of harvested stem cells (in vitro purging), double HDT (cyclophosphamide/epirubicin in the first, busulphan/melphalan in the second) rescued by CD34+-selected cells, the second rescue using cells harvested following the first HDT (in vivo purging) and interferon maintenance.



Results:  Forty-four per cent of patients completed the program. Fifty-three per cent of withdrawals were as a result of insufficient stem cells. This correlated to previous chemotherapy. Therapy-related mortality was 6%. CD34+ selection achieved more than a 2-log reduction of CD38++ cells; in vivo purging achieved 80%. Although similar numbers of CD34+ cells were reinfused at both HDT, platelet recovery was slower after the second HDT. Additional complete remissions were achieved after each phase of therapy, 3% at the end of vincristine, doxorubicin and dexamethasone and 33% after completing planned HDT. Factors associated with longer overall survival included age less than 60 years (P = 0.044), serum β-2-microglobulin below 3 µγ/L at entry (P = 0.042) and less than 2 months between the two HDT (P = 0.024). The only factor associated with a longer event-free survival was less than 2 months between HDT on study (P = 0.038).



Conclusions:  (i) dose intensification with two HDT delivered within 2 months might be associated with a better patient outcome, (ii) early mobilisation should be incorporated in multiple myeloma HDT programs and (iii) higher CD34+ doses may be required for tandem transplants. (Intern Med J 2004; 34: 167−175)

Long-term follow up of sequential mobilisation and autologous transplantation with CD34-selected cells in multiple myeloma: a multimodality approach.

Selected CD34 blood cell allografts for older patients: low transplant-related mortality, graft failure and acute GvHD.

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Granulocyte colony-stimulating factor (G-CSF) dose-dependent efficacy in peripheral blood stem cell mobilization in patients who had failed initial mobilization with chemotherapy and G-CSF

Long-term follow up of sequential mobilisation and autologous transplantation with CD34-selected cells in multiple myeloma: a multimodality approach.

Selected CD34 blood cell allografts for older patients: low transplant-related mortality, graft failure and acute GvHD.