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

Psoriasis Clinical Trial

Official title:

Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894373
• Other study ID #: HWD301
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to determine the therapeutic roles of CIK cells on patients with psoriasis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adoptive Immunotherapy
• Psoriasis

Intervention

Drug:
• Adoptive Immunotherapy
Biological: in vitro expanded Cytokine Induced Killer (CIK) cells Procedure: Infusion of autologous CIK cells

Biological:
• CIK

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	infiltration of immune cells under skin	aberrant infiltration of immune cells within the full-thickness of skin by skin biopsy	6 months
Primary	therapeutic roles of CIK on psoriasis	changes of area and extent of skin lesions	1 year
Secondary	Occurrence of study related adverse events	adverse effect after CIK cell infusion	within 2 weeks