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Autologous Cytokine Induced Killer Cells (CIK) for Patients With Severe Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01894373
Recruitment Status : Completed
First Posted : July 10, 2013
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Study Description
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Brief Summary:
to determine the therapeutic roles of CIK cells on patients with psoriasis

Condition or disease Intervention/treatment Phase
Psoriasis Adoptive Immunotherapy Drug: Adoptive Immunotherapy Biological: CIK Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Psoriasis
Study Start Date : June 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: CIK, psoriasis Drug: Adoptive Immunotherapy
Biological: in vitro expanded Cytokine Induced Killer (CIK) cells Procedure: Infusion of autologous CIK cells

Biological: CIK


Outcome Measures
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Primary Outcome Measures :
  1. therapeutic roles of CIK on psoriasis [ Time Frame: 1 year ]
    changes of area and extent of skin lesions


Secondary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: within 2 weeks ]
    adverse effect after CIK cell infusion


Other Outcome Measures:
  1. infiltration of immune cells under skin [ Time Frame: 6 months ]
    aberrant infiltration of immune cells within the full-thickness of skin by skin biopsy


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have ever had a physician's diagnosis of chronic moderate to severe plaque psoriasis and be a candidate for treatment with CIK Are being treated with or initiating CIK therapy at the time of enrollment Be able to provide written informed consent Be willing and able to fully to participate for the duration of patient follow-up (5 years)

Exclusion Criteria:

  • PUVA or Grenz ray therapy within 4 weeks prior to randomisation. UVB therapy within 2 weeks prior to randomisation. Systemic treatment with biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to randomisation.

Systemic treatment other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine, other immunosuppressants) within 4 weeks prior to randomisation.

Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation (medicated shampoos/emollients are not allowed during the double-blind phase). Shampoos containing corticosteroids, e.g. Clobex®, are not allowed within 2 weeks prior to randomisation.

Planned use of topical treatment for psoriasis of the trunk or limbs, besides study medication, during the study with the exceptions of: • emollient • medications used to treat psoriasis of the skin folds and/or genitals (any medication may be used for this purpose apart from Class 1-5 corticosteroids.

Topical treatment of the face with Class 1-5 corticosteroids within 2 weeks prior to randomisation.

Planned initiation of, or changes to, concomitant medication that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the double-blind phase of the study.

Treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation.

Planned use of chemical treatments of the hair (eg relaxers, 'perms', or colourings) during the double-blind phase of the study.

Current diagnosis of erythrodermic, exfoliative or pustular psoriasis. Patients with any of the following conditions also present on psoriatic areas of the scalp or trunk/limbs: viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, rosacea, acne rosacea, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers or wounds.

Other inflammatory skin diseases that may confound the evaluation of psoriasis of the scalp or trunk/limbs.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01894373


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Director: Han weidong, doctor Institute of immunology，Chinese PLA General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Han weidong, Ph.D, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01894373    
Other Study ID Numbers: HWD301
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: June 2015
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases