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Crohn's DiseasePhase 1/2NCT02000362

Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)

A Phase 1/2 study testing Stem cells in people with Crohn's Disease, run by Kang Stem Biotech Co., Ltd. at 7 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with moderately active Crohn's disease after injection for 28days. The purpose of phase IIa clinical trial is to determine therapeutic safety and efficacy of FURESTEM-CD Inj. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Crohn's Disease
What is being tested?
Stem cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
7 sitesSouth Korea
Study dates
Aug 2014to Oct 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • of either gender, aged≥19 and ≤70 years
  • subjects who is diagnosed with Crohn's disease after considering all the factors below.
  • histological or pathological Diagnostic opinion
  • colonoscopic Diagnostic opinion
  • radiologic and hematological Diagnostic opinion
  • subjects who is included in two criteria below and come under CDAI 220-450 during screening period.
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  • CRP>0.3mg/dL during screening period
  • more than 3 nonanastomotic ulcers which is included in Crohn's disease as a result of colonoscopy on screening period(each diameter of ulcers needs to exceed 0.5cm)
  • range of Crohn's disease : an affection of ileum, an affection of large intestine, an affection of ileum and large intestine at once.
  • subjects who suffer from extensive colitis during more than 8 years or limited colitis during more than 12 years need to have evidence that there are no large intestine ulcers by surveillance colonoscopy on screening visit.
  • subjects who are included in two criteria about drug treatment of Crohn's disease like below.
  • subjects who fail the existing treatment and come under more than 1 criterion as below.
  • subjects who continuously administer Corticosteroid or immunosuppressant (AZA, Methotrexate, 6-MP)
  • subjects who have history of improper response or intolerance about Corticosteroid or immunosuppressant (AZA, Methotrexate, 6-MP)
  • subjects who are dependent Corticosteroid or have history of Corticosteroid dependence.
  • subjects who have history of improper response or intolerance about anti-TNF treatment as below.
  • Infliximab
  • Adalimumab
  • Certolizumab pegol
  • subjects who satisfy those clinical examination value below during screening period.
  • Hemoglobin ≥ 8.0g/dL
  • WBC ≥ 3,000/μL
  • Lymphocyte ≥ 500/μL
  • 100,000/μL ≤ Platelet ≤ 1,200,000/μL
  • AST and ALT ≤ 3 x the upper limit of normal
  • ALP ≤ 3 x the upper limit of normal
  • Serum creatinine ≤ the upper limit of normal
  • Serum albumin ≥ 2.0g/dL
  • PT ≤ the upper limit of normal
  • aPTT ≤ the upper limit of normal
  • subjects who agree with those use of contraceptive method during clinical trial period.
  • woman : subjects who is applicable to more than 1 case below.
  • subjects who is postmenopausal for more than 1 years before screening visit.
  • surgically sterility.
  • If subjects are biological clock, subjects need to agree with prohibition on having sex with man or usage of more than 2 effective contraception from sign of informed consent form until end of the clinical study.
  • man : even surgically sterility(for example, getting a vasectomy), in case of satisfy those conditions below.
  • subjects who agree with prohibition on having sex with woman or usage of effective barrier contraception from sign of informed consent form until end of the clinical study.
  • subjects who understand and voluntarily sign an informed consent form.

Who cannot join

  • Exclusion Criteria of gastrointestinal tract
  • Crohn's disease which is invaded only proximal ileum.
  • the evidence of an intra-abdominal abscess during screening period.
  • the evidence of an abscess around the anus during screening period.
  • conditions of subtotal colectomy or total colectomy.
  • short bowel syndrome.
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  • subjects who conduct elemental diet, tube feeding or parenteral nutrition within 3 weeks before registration.
  • subjects who have ileostomy or colostomy.
  • subjects who remove existing seton before screening period.
  • fixed bowel stricture which has symptoms.
  • In case that the PI anticipate that subjects need to get a surgical intestinal tract surgery caused by Crohn's disease.
  • non-removal of large intestine adenoma.
  • chronic inflammation-associated dysplasia.
  • Exclusion Criteria of drugs
  • in case subjects administered more than one drug within 4 weeks before enrollment.
  • Cyclosporine, tacrolimus, thalidomide
  • Adalimumab
  • Intravenous adrenocortical steroid
  • in case subjects administered more than one drug within 10 weeks before enrollment.
  • Infliximab
  • Cetolizumab pegol
  • All kinds of biologicals
  • in case subjects administered 5-ASA or Corticosteroid local treatment(a suppository or enema) within 2 weeks before enrollment.
  • in case concomitant drug use for CD treatment cannot observe stable dosage during clinical study period or specified period like below.
  • use of oral 5-ASA compound at least 4 weeks before enrollment
  • use of oral Corticosteroid (prednisolone ≤ 20mg/day or budesonide ≤9mg/day) at least 2 weeks before enrollment
  • use of antibiotics for CD treatment at least 2 weeks before enrollment. (ex. metronidazole)
  • use of immunosuppressant at least 4 weeks before enrollment.
  • Exclusion Criteria of infectious disease
  • acute or chronic hepatitis like below(typeA, typeB, typeC).
  • IgM anti-HAV positive
  • HBs-Ag, IgM anti-HBc, IgG anti-HBc positive. (It is possible to enroll the clinical study when a subject is anti-HBs Ab positive, given that the subject is both HBs-Ag and IgM anti-HBc negative or IgG anti-HBc positive.)
  • HCV-Ab positive
  • tuberculosis
  • status present active tuberculosis
  • latent tuberculosis : subjects who is applicable to more than 1 case below.
  • QuantiFERON TB-GOLD positive or 2times continuous indeterminate within 4weeks before registration.
  • more than 10mm in tuberculin skin test within 3 months before registration.(when subjects got injected prednisolone more than 15mg per day, limited tuberculin skin test value is 5mm)
  • In case of observation of pulmonary tuberculosis cicatrix through X-Ray within 3months before registration.
  • All kinds of Congenital or Acquired Immunodeficiency Syndrome.
  • all kinds of live vaccine inoculation except influenza vaccine within 4weeks before registration.
  • Clinically Significant infection with in 4weeks before screening visit or during screening visit.(pneumonia, pyelonephritis, Infection of Clostridium difficile etc.)
  • General exclusion Criteria a. subjects who experienced stem cell therapy. b. History of a malignant tumor except as noted below.
  • properly cured non-metastatic basal cell skin cancer
  • properly cured pinacocyte skin cancer which is not recurred at least 1 year before registration.
  • properly cured carcinoma in situ of uterine cervix which has not recurred at least 3 years before registration.
  • malignant tumor which is not cured yet. d. subjects who are breast-feeding. e. unstable and not regulated disease(associated with cardiovascular, lung, liver, kidney, gastrointestinal tract, urogenital organs, hematologic, immune, endocrine/metabolism, etc.) which has possibility to hamper safety of subjects or cause confusion in clinical study.
  • subjects who got general anesthesia surgery within 4weeks before registration or subjects who anticipated necessity of general anesthesia surgery during clinical study.
  • major neurological history including stroke, multiple sclerosis, encephaloma, neurological degenerative disease.
  • history of hypersensitive reaction about MR contrast medium. I. history of addictive drugs or alcohol with 1 years. j. active psychiatric problem which can hamper participation of clinical study. k. all kinds of problems which has possibility to hamper participation of study visit and observance of study procedure.
  • Any other condition which the PI judges would make subject unsuitable for study participation.
  • subjects who got injected other investigational product within 4 weeks or at present.

Trial locations and contacts

7 sites in 1 country.

Eun-ji Kang contact

ejkang@kangstem.com

7 sites in 1 country

South Korea7 sites, 7 recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Tae-oh Kim

    Recruiting

  • Yeungnam University Medical Center

    Daegu, 42415

    Byung-Ik Jang

    Recruiting

  • Seoul National Universtiy Bundang Hospital

    Seongnam-si, 13620

    Hyuk Yoon

    Hyuk Yoon

    Recruiting

  • Severance Hospital

    Seoul, 03722

    Jae-hee Cheon

    Recruiting

  • Asan Medical Center

    Seoul, 138-736

    Su-jung Kim

    Ji-young Park

    Recruiting

  • Soeul National University Hospital

    Soeul, 110-7441

    Jong-pil Im

    Jong-pil Im

    Recruiting

  • The Catholic University of Korea, St. Vincent'S Hospital.

    Suwon, 16247

    Kang-moon Lee

    Recruiting

Other trials in South Korea

About this study

Official title: An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease

The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with moderately active Crohn's disease after injection for 28days.

The purpose of phase IIa clinical trial is to determine therapeutic safety and efficacy of FURESTEM-CD Inj. which is based on Crohn's disease activity index(CDAI)<150 after injection.

Read the detailed description

Crohn's disease is mysterious chronic inflammatory bowel disease. It usually happen in the young age and last forever. It is not yet clearly known the origin of crohn's disease. However, crohn's disease therapy is getting developed by using immunosuppressant and TNF-alpha inhibitor. Nonetheless, some patients still don't react to TNF-alpha inhibitor which is most effective treatment. Also, Even though some other patients reacted to the treatment at first, the effect of treatment decreases over time. Plus, long-term use of TNF-alpha inhibitor can lead to complication of infection and occurrence of malignant tumor like lymphoma. Recently, treatment of intractable crohn's disease is attempted by using stem cell. Especially, Mesenchymal stem cell is well-known for immunosuppression, anti-inflammatory ability and cell differentiation ability to various lineage cell as non hematopoietic stromal cell.

When the body get infected by the pathogens, innate immune response operate as the primary defence mechanism. at this time, there are some receptors reacting first such as TLR(toll-like receptor) and NLR(nucleotide-binding oligomerization domain) which is located in the cytoplasm of a cell. It is reported that the activities of TLR which is expressed by Mesenchymal stem cells play an important roles about immunomodulatory ability of Mesenchymal stem cells. Furthermore, human Umbilical Cord Blood derived-Universal Stem Cells( hUCB-USCs) manifest TLR and NLR of Mesenchymal Stem cells at the same time. when those receptors become activation, it maximize ability of immunomodulatory. Therefore, hUCB-USCs can be utilized to cure intractable autoimmune disease like Crohn's disease. Further, It has huge possibility as cell therapy products for autoimmune disease.

Conditions
Crohn's Disease
Being tested
Stem cells
Keywords
Crohn's Disease, Stem cell, Cell therapy, Auto-immune disease, furestem, CD, inflammatory bowel disease, MSCs, Mesenchymal Stem Cells, hUCB-MSC, UCB-MSC, Umbilical cord Blood
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stem cellsBiological

    Also called FURESTEM-CD Inj.

Study groups in NCT02000362
Study groupRoleWhat they receive
TreatmentExperimentalcohort 1. 5.0 x 10^7 stem cells after registration cohort 2. 1.0 x 10^8 stem cells after registration
Receives: Biological: Stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events, Ratio of patients who is applicable to CDAI<150

    on phase 1, Phase 2a

    Measured: 4 weeks follow-up after treatment, 12 weeks follow-up after treatment

Secondary outcomes (8)

  1. the ratio of patients who reduce CDAI over 70 as contrasted with baseline value

    on phase 2a

    Measured: 12 weeks follow-up after treatment

  2. a variation of CRP value as contrasted with baseline

    on phase 2a

    Measured: 12 weeks follow-up after treatment

  3. a variation of MR enterographic score as contrasted with baseline

    on phase 2a

    Measured: 12 weeks follow-up after treatment

  4. a variation of fecal calprotectin as contrasted with baseline

    on phase 2a

    Measured: 12 weeks follow-up after treatment

  5. a variation of IBDQ score as contrasted with baseline

    on phase 2a

    Measured: 12 weeks follow-up after treatment

  6. a variation of SF-36 score as contrasted with baseline

    on phase 2a

    Measured: 12 weeks follow-up after treatment

  7. reduction of the number of draining fistula

    on phase 2a

    Measured: 12 weeks follow-up after treatment

  8. all kinds of adverse effects which occur during the clinical study

    on phase 2a

    Measured: 12 weeks follow-up after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2013 (estimated)
  2. Study startAug 2014
  3. Primary completionSep 2018 (estimated)
  4. Study completionOct 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02000362
Sponsor's protocol ID
KSTHD_FURESTEM-CD
Status last verified
Sep 2016
First submitted
7 Nov 2013
Last updated
6 Sep 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Stem cells in people with Crohn's Disease, run by Kang Stem Biotech Co., Ltd. at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eun-ji Kang (ejkang@kangstem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events, Ratio of patients who is applicable to CDAI<150 (time frame: 4 weeks follow-up after treatment, 12 weeks follow-up after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02000362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.

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