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Critical Limb IschemiaPhase 1NCT02477540

A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia

A Phase 1 study testing Cellgram-CLI in people with Critical Limb Ischemia, run by Pharmicell Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Critical Limb Ischemia
What is being tested?
Cellgram-CLI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2019to Jun 2020
Phase
Phase 1
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age from 20 to 80 years
  • Patients with resting pain or ulceration of limb (Rutherford's class: II-4, III-5 or III-6)
  • Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or TCPO2 ≤ 60mmHg in the foot
  • Patients who were unsuitability for percutaneous transluminal angioplasty or a bypass operation
  • Patients who are not expected other treatments for at least 6 months
  • Patients who can agree to participate in the clinical trial by oneself or by one's legal representative
  • Patients who can conduct the clinical trial according to the protocol

Who cannot join

  • Buerger's disease
  • History of hematologic disease
  • Patients who are at risk of embolism due to atrial fibrillation
  • Primary hematologic disease, including hypercoagulable states
  • Entrapment syndrome
  • Patients with osteomyelitis
Show all 27Show fewer
  • Patients whose blood serum AST(Aspartate transaminase)/ALT(Alanine Transaminase) rates are more than three times the normal maximum rate, or whose creatinine rates are more than 1.5 times the normal maximum rate
  • Patients with history of anaphylaxis to gentamicin
  • Patients with hypersensitivity of bovine-derived ingredients
  • Patients with chronic heart failure, Glomerular disease and Obstructive pulmonary disease
  • Patients with Stroke or transient ischemic attack within 6 months prior to registration
  • Patients tested positive for HIV(Human Immunodeficiency Virus), HCV(Hepatitis C Virus), HBV(Hepatitis B Virus) and Syphilis
  • Patients with history of aorta and artery bypass operation, or angioplasty within 2 months recently
  • Patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia
  • Patients with history of cell therapy
  • Type I diabetes
  • Uncontrolled diabetes mellitus (HgbA1C>8%)
  • Uncontrolled hypertension
  • Has a medical record of solid cancer, or diagnosed with solid cancer and currently receiving cancer treatment
  • Positive of tumor markers test(AFP((Alpha fetoprotein), CEA(Carcinoembryonic antigen), CA15-3(Cancer antigen 15-3 for breast cancer) and PSA(Prostate-specific antigen), or have received a diagnosis of cancer based on National cancer screening program
  • Pregnancy, possible candidate for pregnancy or lactating women
  • Infectious disease
  • Administrating of immunosuppressive agents, corticosteroid formulation and cell toxicity formulation, or requiring administration of the test period
  • Patients already enrolled in another clinical trials or completed within 3 months
  • Patients who cannot adapt to the protocol and follow-up observation
  • Patients who has experienced drug abuse for the past 1 year
  • Patients with any disease or condition which the investigator fell would interfere with trial or the safety of the subject

About this study

Official title: An Open Labeled, Single-center, Phase I Study Assessing the Safety and Efficacy of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia

This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.

Read the detailed description

If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability.

A participant that satisfies all inclusion and exclusion criteria is assigned a test group(2-time injection group).

Participants conduct cell therapy within 30 days after bone marrow aspiration, and will re-inject autologous mesenchymal stem cells within 30 days after first injection.

Participants will make a total of 5 hospital visits after registration, and Safety and Efficacy will be evaluated based on a fixed procedure on every visit.

Being tested
Cellgram-CLI
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

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

  • Cellgram-CLIDrug

    Also called Autologous bone marrow derived Mesenchymal Stem Cells

    Appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip

    Main ingredient: Autologous bone marrow-derived mesenchymal stem cells

    Dosage: 50,000,000 cells/10ml, 2-time injection

    Storage: An airtight container, 20~25℃

    Injection Method: Intramuscular

Study groups in NCT02477540
Study groupRoleWhat they receive
2-time injection group : Cellgram-CLIExperimentalWithin 30 days after extracting bone marrow, autologous bone marrow-derived mesenchymal stem cells is directly injected into the lesion. Then the second cell is injected within 30 days after the first cell injection.
Receives: Drug: Cellgram-CLI

What is being measured

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

  1. Ankle Brachial Pressure Index, ABPI

    Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of between the two visits(Screening and 6 month post treatment) before and after treatment.

    Measured: 6 months after BM-MSC therapy

Secondary outcomes (9)

  1. Collateral vessel formation on digital subtraction angiography (DSA)

    Analyze the difference of pre and post treatment using McNemar test for homogeneity test.

    Measured: 6 months after BM-MSC therapy

  2. Difference of Wound size

    Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post treatment Healing of ulcerations (change in size of ulcers) or reduction of ulcer area in the target limb.

    Measured: 6 months after BM-MSC therapy

  3. Improved transcutaneous oxygen pressure (TCPO2)

    Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post treatment transcutaneous oxygen pressure (TCPO2).

    Measured: 6 months after BM-MSC therapy

  4. Pain on the Visual Analogue Scale(VAS)

    Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post Visual Analogue Scale(VAS).

    Visual Analogue Scale(VAS):

    Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

    the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

    Measured: 6 months after BM-MSC therapy

  5. Reduced limb amputation

    Described and define as minor amputation is below midtarsal level, major amputation is more than midtarsal level.

    Measured: 6 months after BM-MSC therapy

  6. Temperature change on thermography

    Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post thermography.

    Measured: 6 months after BM-MSC therapy

  7. Dose about using analgesic medicine

    Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference between pre and post dose of the using analgesic medicine.

    Measured: 6 months after BM-MSC therapy

  8. Change in Rutherford classification

    Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of pre and post Rutherford classification.

    Rutherford classification: commonly used clinical staging system for describing peripheral arterial disease.

    Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

    Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

    Measured: 6 months after BM-MSC therapy

  9. Frequency about using analgesic medicine

    Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference between pre and post frequency of the using analgesic medicine.

    Measured: 6 months after BM-MSC therapy

Timeline

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

  1. First posted22 Jun 2015 (estimated)
  2. Study startDec 2019 (estimated)
  3. Primary completionJun 2020 (estimated)
  4. Study completionJun 2020 (estimated)

Why it stopped: Study was stopped by sponsers internal reason.

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477540
Sponsor's protocol ID
Cellgram-CLI
Status last verified
Mar 2019
First submitted
10 Jun 2015
Last updated
22 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cellgram-CLI in people with Critical Limb Ischemia, run by Pharmicell Co., Ltd..

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 7 inclusion and 27 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: withdrawn, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ankle Brachial Pressure Index, ABPI (time frame: 6 months after BM-MSC therapy). 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 NCT02477540.

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 22 Mar 2019.

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