NCT03440541

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

November 29, 2017

Last Update Submit

June 26, 2019

Conditions

Psoriasis

Keywords

Amniotic membranePsoriasisTreatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Erythema disappearing

    4-6 weeks

Study Arms (1)

treated

EXPERIMENTAL

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

Combination Product: REGE pro

Interventions

REGE proCOMBINATION_PRODUCT

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

treated

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients have psoriasis lesion

You may not qualify if:

  • must stop other line of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amniotic tissue lab

Cairo, 29, Egypt

Location

Related 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.

    PMID: 26306147BACKGROUND

  • 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.

    PMID: 7616005BACKGROUND

  • 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.

    PMID: 25140001BACKGROUND

  • 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.

    PMID: 26523059BACKGROUND

  • 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.

    PMID: 11825823BACKGROUND

  • 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.

    PMID: 21381973BACKGROUND

  • 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.

    PMID: 25333453BACKGROUND

  • 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.

    PMID: 22398715BACKGROUND

  • 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.

    PMID: 25259480BACKGROUND

  • 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.

    PMID: 26573299BACKGROUND

  • 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.

    PMID: 26036872BACKGROUND

  • 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.

    PMID: 25348066BACKGROUND

  • 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.

    PMID: 21869882BACKGROUND

  • 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.

    PMID: 24551087BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nashwa K Radwan, PhD

    NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 29, 2017

First Posted

February 22, 2018

Study Start

August 4, 2015

Primary Completion

February 13, 2016

Study Completion

April 8, 2016

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

EG(1)