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

NCT ID: NCT03440541

Last Updated: 2019-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-04

Study Completion Date

2016-04-08

Brief Summary

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

Detailed Description

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

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treated

Patients who received patches of REGE pro on psoriasis lesion weekly for 8 weeks

Group Type EXPERIMENTAL

REGE pro

Intervention Type COMBINATION_PRODUCT

REGE pro is a patch of human amniotic membrane sterilized by gamma radiation

Interventions

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REGE pro

REGE pro is a patch of human amniotic membrane sterilized by gamma radiation

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* patients have psoriasis lesion

Exclusion Criteria

* must stop other line of treatment
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Egyptian Atomic Energy Authority

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nashwa Radwan

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nashwa K Radwan, PhD

Role: STUDY_DIRECTOR

NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

Locations

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Amniotic tissue lab

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 26306147 (View on PubMed)

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. doi: 10.1111/1523-1747.ep12316121.

Reference Type BACKGROUND
PMID: 7616005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25140001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26523059 (View on PubMed)

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. doi: 10.1016/s0161-6420(01)00900-9.

Reference Type BACKGROUND
PMID: 11825823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21381973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25333453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22398715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25259480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26573299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26036872 (View on PubMed)

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 Rep. 2015 Jun;11(3):394-407. doi: 10.1007/s12015-014-9558-4.

Reference Type BACKGROUND
PMID: 25348066 (View on PubMed)

Redondo P, Gimenez de Azcarate A, Marques L, Garcia-Guzman M, Andreu E, Prosper 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.

Reference Type BACKGROUND
PMID: 21869882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24551087 (View on PubMed)

Other Identifiers

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4102017NCRRT

Identifier Type: -

Identifier Source: org_study_id

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