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AUTOLOGOUS STEM CELLS IMPLANTS IN PSORIASIS

 

Pilot study comparing with PUVA-systemic therapy

*Zurita G, **Geffner L, ***Maldonado B, ****Uraga E, ****Armijos L.

 

Background:

Psoriasis is a common inflammatory disease of the skin marked by excessive scaling associated with inflammation, affecting about 2 % of the word population (1). The severity of psoriasis runs from relatively minor disease consisting of 1 or 2 small plaques to erythrodermic psoriasis covering the entire cutaneous surface. Many treatments have been developed for psoriasis, none of them satisfying the whole therapeutic needs in terms of disease control, relapses and collateral effects, which in many cases turn their repeated use unadvisable.

 

Clinical trials have reported early remission of refractory autoimmune disorders, including diabetes mellitus, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, after autologous hematopoietic stem cells transplantation (2, 3). In reference with psoriasis we have found several reports about a patient with leukemia and severe psoriasis who, after allogeneic bone marrow transplantation, experienced remission of psoriasis (4, 5, 6, 7, 8). Having this possibility in mind we have designed a study to investigate the use of autologous stem cells implants as a new therapy of psoriasis.

 

Objective:

Determine if intravenous implanting of authologous SC have any therapeutic effect in psoriasis, and if it is comparable with an established treatments for psoriasis like Systemic-PUVA-therapy.

 

Patients and Method:

Patient selection: Patients suffering from psoriasis attending the Dermatology Department of the Luis Vernaza Hospital were included in the study if, the baseline Psoriasis Area Severity Index (PASI) was equal or higher than 10, older than 18 years, any types of psoriasis were considered. Patients were not receiving or had received phototherapy UVB, Psoralen plus UVA radiation (PUVA), oral retinoids, immunosuppressive or biologic agents within the last month; but could receive a topic treatment (corticoid, salycilic acidic, moisturizer) Patients were willing and motivated to participate in this study; they were allocated in two groups according their preference after being orally informed: patients who received autologous SC, and patients who received systemic PUVA-therapy. An informed consent was signed.

 

Group 1 (Autologous stem cells group): Cardiologic evaluations including chest X-ray and EKG, haematic biometry, HIV determination and coagulation profile were performed prior to the implants. Evidence of alcohol or drug abuse, morbid obesity, mild to severe coagulopathy (clothing time higher than twice the normal range) and patients who take anti clothing drugs were excluded. Bone marrow was harvested from both iliac crests under epidural anaesthesia with bupivacaine 0.5%. It was processed by repeated centrifugation and the CD34 + fraction was separated by difference in density by submerging it into a ficol solution (density 1072). The final volume was about 110+/- ml. Once the cell suspension was obtained it was infused intravenously once diluted in 100 ml of saline solution in 15 minutes.

 

Group 2 (Systemic- PUVA therapy group): Irradiation was performed using Houva II (National Biologic) cabinet with 24 UVA (F72T12 BL/HO) lamps. Treatment was given tree times a week. Liver and renal function test were performed before initiation of therapy. Patients were instructed to ingest 8-methoxypsoralen (0.3 mg/kg, 2 hours before exposure). Standard initial dose of 1 J/cm2 was started on all patients. The irradiation dose was increased by 1J/cm2 for each subsequent visit until 15 J/cm2 or 100% clear was achieved.

 

Clinical assessment: In both groups, disease severity assessments comprising Psoriasis Area Severity Index (PASI) were performed by a dermatologist at baseline and at weeks 1, 2, 3, 4, 12 and 24. Reduction mean PASI values were assessed. A 75% of PASI reduction was established as goal (PASI 75); it was evaluated at 1, 4 and 12 weeks. In all cases digital pictures were taken.

 

Statistical analysis:

In accordance with descriptive statistics, mean ± standard deviation values were used. ANOVA test and Student’s Newman Keuls test were used to compare reduction mean PASI in autologous SC patients vs. those receiving PUVA therapy. P<0.05 was considered as statistically significant. To determine the PASI 75 we used the Proportion Hypothesis test.

 

Results:

A total of 30 patients (13 women and 17 men; 50±11 years old age average and 24±10 baseline PASI average) were treated with autologous SC implant. Meanwhile, 19 patients (3 women and 16 men; 45±12 years old; baseline PASI: 23±12) were treated with systemic PUVA-therapy. From the first group, 8 patients quitted and remained 22 at week 24.  From the second group, 6 quitted and remained 13 at week 24.

 

PASI reductions mean values for those who received autologous SC implant was: 20.2±47.2% (CI 95%:0.378/0.026); 21.6±50.8% (CI 95%0.406/0.026) 29.2±51.6% (CI 95% 0.485/0.1), 31.5±55.8% (CI 95%:0.523/0.107); 55±40% (CI 95%:0.720/0.380); 63±30.9% (CI 95%:0.766/0494),  at 1, 2, 3, 4, 12 and 24 weeks respectively.  For those who received systemic PUVA-therapy PASI reduction mean values were: 14±17% (CI 95%:0.228/0.052); 21±47.3% (CI 95%:0309/0.052); 35±28.8% (CI 95%:0.499/0.202);  43.4±38% (CI 95%:0.629/0.238); 66.4±35.9% (CI 95%:0.871/0.456); 61±31% (CI 95%:0.79/0.44) at 1, 2, 3, 4, 12  and 24 weeks respectively.  There was not a significant difference between both treatments (week 1: p-value= 0.60; week 4: p-value=0.44; week 12: p-value=0.39).

 

PASI 75 in SC group was reached by 40% (p=0.11), 47% (p=0.51) and 55% (p=0.92) at 4, 12 and 24 weeks. In PUVA group: 40% (p=0.5); 65% (p=0.068) and 65% ( p=0.080) at 4, 12 and 24 weeks respectively.

 

Conclusions: In our study we have found that autologous SC implant in psoriasis patients presents no statistically significant differences when compared with PUVA-systemic. At 4 weeks 40% of the SC group and PUVA group got success (PASI 75), at 12 weeks it was 47% and 65% respectively, whiles at 24 weeks it was 55% and 65% respectively.  

 

Nevertheless, results of this study encourage longer follow up, and more cases need to be studied. This has been a pilot study through which we have determined the correct size of the universe for an appropriate evaluation of this prospective therapy. Using the formula to calculate the size of the sample for proportions () (9) with 95% confidence, with 5% error range,     and considering that the incidence of psoriasis in Latin America population is 1%, with a population of 13´000,000.00 (Ecuador), and that we have obtained a 55% of PASI 75 at 24 weeks, the proper statistical universe size for an adequate study must be 380 patients.

 

References

1.- Christophers E. Psoriasis-epidemiology and clinical spectrum. Clin Exp Dermatol. 2001;26:314-20

2.- Burt R K, Slavin S, Burns W H, Marmont A M. Induction of tolerance in autoimmune diseases by hematopoietic stem cell transplantation: getting closer to a cure?. Blood Rev. 2002; 99, 3:768-784

3.- Fassas A, Kimiskidis V K.. Stem cell transplantation for multiple sclerosis: what is the evidence?. Blood Rev. 2003;17,4:233-40

4.- Eedy DJ, Burrows D, Bridges JM, Jones FG. Clearance of severe psoriasis after allogeneic bone marrow transplantation. BMJ I990; 300:908

5.- Kishimoto Y, Yamamoto Y, Ito T et al. Transfer of autoimmune thyroiditis and resolution of palmoplantar pustular psoriasis following allogeneic bone marrow transplantation. Bone Marrow Transplant 1997; 19: 1041-1043, MEDLINE

6.- Jowitt SN, Liu Yin JA. Psoriasis and bone marrow transplantation. BMJ 1990; 300:1398-1399, MEDLINE

7.- Liu Yin JA, Jowitt SN. Resolution of immune-mediated diseases following allogeneic bone marrow transplantation for leukaemia. Bone Marrow Transplant 1992;9:31-33, MEDLINE

8.- Adkins D R, Abidi M H, Brown R A, Khoury H, Goodnough L T, Vij R, Westervelt P, DiPersio J F. Resolution of psoriasis after allogeneic bone marrow transplantation for chronic myelogenous leukemia: late complications. A J Hem.2000;26,11:1239-1241

9.-Ríus F, Barón FF J,, Sanchez E, Parra L. nombre del capitulo. En: Editores. Bioestadística: métodos. y aplicaciones. Universidad de Málaga. Año del libro. P. 187-88

 

*Dermatologist, Luis Vernaza Hospital’s Phototherapy Department.

**Director, Program of Investigation on Stem Cells, Luis Vernaza Hospital.

*** Hematologist,  Sociedad Lucha contra el Cancer Hospital (SOLCA).

****Chief Dermatologist, Luis Vernaza Hospital’s Dermatology Department

*****Science Master, Luis Vernaza Hospital’s Stadistic Department

 

Autor:

GILDA ZURITA SALAZAR MD

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E-mail: mdgiloren@yahoo.es
Página web: www.dragildazurita.com
Guayaquil, Ecuador.                                                      

 

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