ClinicalTrials.gg
CompletedNCT03440541Updated Jun 27, 2019

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

An interventional study of REGE pro in Psoriasis, sponsored by Egyptian Atomic Energy Authority. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-27.

Sponsored by Egyptian Atomic Energy Authority · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Aug 2015, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Psoriasis with a site in Egypt — 16 open to participants now, 16 under way, 2 of them phase 3. Psoriasis · Egypt.

Enrollment
41st of 43
22 · median 40
Started
2015
with 1 other
No phase
24 of 54
7 open now
Registered
7th of 54
by date

Among the 54 studies in Psoriasis with a site in Egypt, this one is the 41st largest by enrollment of the 43 interventional ones, is one of 2 that started in 2015, is one of 24 with no phase, and was the 7th registered.

By phase

54 studies; the count open now beside each. This study's row is marked.

No phasethis study24 · 7 open
Observational11 · 3 open
Phase 49 · 2 open
Phase 34 · 2 open
Phase 13 · 1 open
Phase 22 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 2010; this study’s year is marked. 2 started in 2015.

Size and results

Median enrollment 40 across the 43 interventional studies, 100 across the 11 observational. Of the 27 that completed or were terminated, 2 (7%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 54 studies in Psoriasis with a site in Egypt, or all of them as a file.
02

Study summary

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

Read the detailed description

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

03

Conditions studied

  • Psoriasis

Browse trials for

Keywords

  • Amniotic membrane
  • Psoriasis
  • Treatment
04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients have psoriasis lesion

Exclusion criteria

Exclusion Criteria:

  • must stop other
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    treated

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

    Combination Product: REGE pro

Interventions

  • Combination productREGE pro

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 weeks

  2. 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.

    Time frame: 6 weeks

Secondary outcomes

  1. Erythema disappearing

    REGE pro gel gradually decreased erythema in patients within 4-6 weeks, these data were collected from applied patients by questionnaire.

    Time frame: 4-6 weeks

07

Study locations

1 site
  • Amniotic tissue lab
    Cairo, 29, Egypt
08

References and documents

Publications

  • 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. PubMed 26306147 ↗
  • 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. PubMed 7616005 ↗
  • 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. PubMed 25140001 ↗
  • 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. PubMed 26523059 ↗
  • 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. PubMed 11825823 ↗
  • 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. PubMed 21381973 ↗
  • 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. PubMed 25333453 ↗
  • 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. PubMed 22398715 ↗
  • 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. PubMed 25259480 ↗
  • 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. PubMed 26573299 ↗
  • 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. PubMed 26036872 ↗
  • 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. PubMed 25348066 ↗
  • 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. PubMed 21869882 ↗
  • 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. PubMed 24551087 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2015 to primary completion in Feb 2016, 6 months.

Of 115 non-industry interventional studies with no phase under Psoriasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 6 months is below that.

Counting every sponsor, half of 134 studies reached it within 19 months; a quarter within 8 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2017
First posted
Feb 22, 2018
StartActual
Aug 4, 2015
Primary completionActual
Feb 13, 2016
CompletionActual
Apr 8, 2016
Last update
Jun 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03440541
Lead sponsor
Egyptian Atomic Energy Authority
Responsible party
Nashwa Radwan (Director, Egyptian Atomic Energy Authority) — Principal investigator
First posted
Feb 22, 2018
Start date
Aug 4, 2015
Primary completion
Feb 13, 2016
Completion
Apr 8, 2016
Last update
Jun 27, 2019

Study contacts

Nashwa K Radwan, PhD
study director · NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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