Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment

Psoriasis Clinical Trial

Official title:

Uses of Gamma Irradiated Amniotic Membrane as an Alternative Method in Psoriasis Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440541
• Other study ID #: 4102017NCRRT
• Status: Completed
• Phase: N/A
• Start date: August 4, 2015
• Est. completion date: April 8, 2016

Study information

• Verified date: June 2019
• Source: Egyptian Atomic Energy Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using of human amniotic membrane extra-cellular matrix as a topical treatment for improving Psoriasis Area and Severity Index (PASI).

Description:

Human amniotic membrane extra-cellular matrix was purchased from National center for radiation research and technology, Egypt, under commercial name REGE pro gel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 8, 2016
• Est. primary completion date: February 13, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• patients have psoriasis lesion

Exclusion Criteria:

• must stop other line of treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Combination Product:
• REGE pro
REGE pro is a patch of human amniotic membrane sterilized by gamma radiation

Locations

Country	Name	City	State
Egypt	Amniotic tissue lab	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Atomic Energy Authority

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

Alikarami F, Yari F, Amirizadeh N, Nikougoftar M, Jalili MA. The Immunosuppressive Activity of Amniotic Membrane Mesenchymal Stem Cells on T Lymphocytes. Avicenna J Med Biotechnol. 2015 Jul-Sep;7(3):90-6. — View Citation

Bata-Csorgo Z, Hammerberg C, Voorhees JJ, Cooper KD. Intralesional T-lymphocyte activation as a mediator of psoriatic epidermal hyperplasia. J Invest Dermatol. 1995 Jul;105(1 Suppl):89S-94S. Review. — View Citation

Chen CP, Chen YY, Huang JP, Wu YH. The effect of conditioned medium derived from human placental multipotent mesenchymal stromal cells on neutrophils: possible implications for placental infection. Mol Hum Reprod. 2014 Nov;20(11):1117-25. doi: 10.1093/molehr/gau062. Epub 2014 Aug 19. — View Citation

Gisondi P, Di Mercurio M, Idolazzi L, Girolomoni G. Concept of Remission in Chronic Plaque Psoriasis. J Rheumatol Suppl. 2015 Nov;93:57-60. doi: 10.3899/jrheum.150638. Review. — View Citation

John T, Foulks GN, John ME, Cheng K, Hu D. Amniotic membrane in the surgical management of acute toxic epidermal necrolysis. Ophthalmology. 2002 Feb;109(2):351-60. — View Citation

Kronsteiner B, Wolbank S, Peterbauer A, Hackl C, Redl H, van Griensven M, Gabriel C. Human mesenchymal stem cells from adipose tissue and amnion influence T-cells depending on stimulation method and presence of other immune cells. Stem Cells Dev. 2011 Dec;20(12):2115-26. doi: 10.1089/scd.2011.0031. Epub 2011 Apr 19. — View Citation

Li J, Koike-Soko C, Sugimoto J, Yoshida T, Okabe M, Nikaido T. Human Amnion-Derived Stem Cells Have Immunosuppressive Properties on NK Cells and Monocytes. Cell Transplant. 2015;24(10):2065-76. doi: 10.3727/096368914X685230. Epub 2014 Oct 20. — View Citation

Ma L, Zhou Z, Zhang D, Yang S, Wang J, Xue F, Yang Y, Yang R. Immunosuppressive function of mesenchymal stem cells from human umbilical cord matrix in immune thrombocytopenia patients. Thromb Haemost. 2012 May;107(5):937-50. doi: 10.1160/TH11-08-0596. Epub 2012 Mar 8. — View Citation

Magatti M, Caruso M, De Munari S, Vertua E, De D, Manuelpillai U, Parolini O. Human Amniotic Membrane-Derived Mesenchymal and Epithelial Cells Exert Different Effects on Monocyte-Derived Dendritic Cell Differentiation and Function. Cell Transplant. 2015;24(9):1733-52. doi: 10.3727/096368914X684033. Epub 2014 Aug 19. — View Citation

Mahil SK, Capon F, Barker JN. Update on psoriasis immunopathogenesis and targeted immunotherapy. Semin Immunopathol. 2016 Jan;38(1):11-27. doi: 10.1007/s00281-015-0539-8. Epub 2015 Nov 16. Review. — View Citation

McDonald CA, Payne NL, Sun G, Moussa L, Siatskas C, Lim R, Wallace EM, Jenkin G, Bernard CC. Immunosuppressive potential of human amnion epithelial cells in the treatment of experimental autoimmune encephalomyelitis. J Neuroinflammation. 2015 Jun 3;12:112. doi: 10.1186/s12974-015-0322-8. — View Citation

Pianta S, Bonassi Signoroni P, Muradore I, Rodrigues MF, Rossi D, Silini A, Parolini O. Amniotic membrane mesenchymal cells-derived factors skew T cell polarization toward Treg and downregulate Th1 and Th17 cells subsets. Stem Cell Rev. 2015 Jun;11(3):394-407. doi: 10.1007/s12015-014-9558-4. — View Citation

Redondo P, Giménez de Azcarate A, Marqués L, García-Guzman M, Andreu E, Prósper F. Amniotic membrane as a scaffold for melanocyte transplantation in patients with stable vitiligo. Dermatol Res Pract. 2011;2011:532139. doi: 10.1155/2011/532139. Epub 2011 Aug 18. — View Citation

Yamahara K, Harada K, Ohshima M, Ishikane S, Ohnishi S, Tsuda H, Otani K, Taguchi A, Soma T, Ogawa H, Katsuragi S, Yoshimatsu J, Harada-Shiba M, Kangawa K, Ikeda T. Comparison of angiogenic, cytoprotective, and immunosuppressive properties of human amnion- and chorion-derived mesenchymal stem cells. PLoS One. 2014 Feb 14;9(2):e88319. doi: 10.1371/journal.pone.0088319. eCollection 2014. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scaling size decrement	REGE pro gel decreased scaling size in patients with sever scales to moderate scale within two weeks, scaling size decrement from moderate to mild within two weeks, and from mild to complete curing within two weeks	2 weeks
Primary	Histopathological improvement	Two biopsies were taken from each patient before and at the end of the treatment. It was noted that all histological signs as munro's microabscess and the elongation of rete ridges were absent.	6 weeks
Secondary	Erythema disappearing	REGE pro gel gradually decreased erythema in patients within 4-6 weeks, these data were collected from applied patients by questionnaire.	4-6 weeks