NCT02918123

Brief Summary

Phase I clinical trial to evaluate safety of FURESTEM-CD Inj. in patients with moderate to severe in plaque-type psoriasis injection for 4weeks.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 17, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

3.9 years

First QC Date

September 27, 2016

Last Update Submit

March 13, 2018

Conditions

Psoriasis

Keywords

PsoriasisPlaque psoriasisStem cellCell therapyFurestemMesenchymal stem cellMSCUmbilical cord bloodhUCB-MSCUCB-MSC

Outcome Measures

Primary Outcomes (3)

  • number of adverse events

    4 weeks follow-up after treatment

  • safety lab tests, physical examination, ECG, vital signs

    4 weeks follow-up after treatment

  • variation of Cytokine, PASI, BSA

    4 weeks follow-up after treatment

Other Outcomes (1)

  • number of adverse events, safety lab tests, physical examination, vital signs

    144 weeks follow-up after treatment (Extension study)

Study Arms (1)

Treatment

EXPERIMENTAL

1. FURESTEM-CD Inj. 5.0x10\^7 cells 2. FURESTEM-CD Inj. 1.0x10\^7 cells 3. FURESTEM-CD Inj. 2.0x10\^8 cells

Biological: FURESTEM-CD Inj.

Interventions

FURESTEM-CD Inj.BIOLOGICAL

Patients will be treated FURESTEM-CD Inj. Subcutaneous injection

Also known as: hUCB-MSCs
Treatment

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old(both sexes)
  • Have been diagnosed with plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis\[PsA\] may be enrolled)
  • Psoriasis Area and Severity Index (PASI) score \>= 12 at screening
  • BSA(Body Surface Area) \>= 10 percentage at screening
  • Have had at least one of the following conventional systemic agent for the treatment of psoriasis,
  • MTX, Cyclosporine, Photochemotherapy, TNF-alpha inhibitor or IL-12/IL-23 inhibitor
  • Subject who would agree to avoid prolonged sun exposure, use of tanning booths or other ultraviolet light sources during the clinical study
  • Subject who understands and voluntarily signs the informed consent form

You may not qualify if:

  • Subject who has other types of psoriasis (eg. Erythrodermic, guttate, or pustular)
  • Have a history of chronic or recurrent infectious disease
  • Have received phototherapy or any systemic medications/treatments within 4 weeks of screening that could affect psoriasis or PASI evaluation
  • Have used topical medications/treatments within 2 weeks of screening that could affect psoriasis or PASI evaluation
  • Have used any systemic immunosuppressants within 4 weeks of screening
  • Have been administered with the following biological agents that could affect plaque-type psoriasis
  • Etanercept - within 4 weeks of screening
  • Adalimumab, alefacept, infliximab - within 2 months of screening
  • Ustekinumab - within 4 weeks of screening
  • Other investigational biological agents - within 4 weeks of screening/five half-lives(whichever was longer)
  • Pregnant, breast-feeding women or women who plan to become pregnant during this study (Females of childbearing potential must have a negative urine pregnancy test at screening)
  • Have been administered any types of investigational drugs within the previous 4 weeks or five half-lives of the investigational agent, whichever is longer
  • Subject who already took or need to take medicine which is prohibited during the clinical study
  • Subject who has sever dyshepatia (Creatinine value ≥ 2X Upper limit of the normal range at screening test)
  • Subject who has severe renal dysfunction (AST/ALT value ≥ 2X Upper limit of the normal range at screening test)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic Univ. Korea Seoul, St. Marry's Hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Taeyoon Kim

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunji Kang

CONTACT

82-2-2036-7533ejkang@kangstem.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

January 17, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

KR(1)