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

• ClinicalTrials.gov Identifier: NCT01894373
• Recruitment Status: Completed
• First Posted: July 10, 2013
• Last Update Posted: May 17, 2018
• Sponsor: Chinese PLA General Hospital
• Information provided by (Responsible Party): Han weidong, Chinese PLA General Hospital

Tracking Information

• First Submitted Date: June 27, 2013
• First Posted Date: July 10, 2013
• Last Update Posted Date: May 17, 2018
• Study Start Date: June 2015
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 3, 2013)

therapeutic roles of CIK on psoriasis [ Time Frame: 1 year ]

changes of area and extent of skin lesions

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 3, 2013)

Occurrence of study related adverse events [ Time Frame: within 2 weeks ]

adverse effect after CIK cell infusion

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 3, 2013)

infiltration of immune cells under skin [ Time Frame: 6 months ]

aberrant infiltration of immune cells within the full-thickness of skin by skin biopsy

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Autologous Cytokine Induced Killer Cells (CIK) for Patients With Severe Psoriasis
• Official Title: Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Psoriasis
• Brief Summary: to determine the therapeutic roles of CIK cells on patients with psoriasis
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Psoriasis
• Adoptive Immunotherapy

Intervention

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

Study Arms

Experimental: CIK, psoriasis

Interventions:

• Drug: Adoptive Immunotherapy
• Biological: CIK

• Publications *: Dai H, Zhou Y, Tong C, Guo Y, Shi F, Wang Y, Shen P. Restoration of CD3(+)CD56(+) cell level improves skin lesions in severe psoriasis: A pilot clinical study of adoptive immunotherapy for patients with psoriasis using autologous cytokine-induced killer cells. Cytotherapy. 2018 Sep;20(9):1155-1163. doi: 10.1016/j.jcyt.2018.07.003. Epub 2018 Aug 9.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 3, 2013): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2017
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01894373
• Other Study ID Numbers: HWD301
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Han weidong, Chinese PLA General Hospital
• Study Sponsor: Chinese PLA General Hospital
• Collaborators: Not Provided

Investigators

• Study Director: Han weidong, doctor; Institute of immunology，Chinese PLA General Hospital

• PRS Account: Chinese PLA General Hospital
• Verification Date: June 2015