The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM

  • STATUS
    Recruiting
  • End date
    Jul 31, 2023
  • participants needed
    78
  • sponsor
    Ixaka Ltd
Updated on 29 January 2022
estrogen
hemoglobin a1c
glycosylated hemoglobin
ischemic ulcer
revascularisation

Summary

This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.

Details
Condition Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Cardiovascular Disease, Critical Limb Ischemia (CLI)
Treatment Placebo, Rexmyelocel-T, REX-001
Clinical Study IdentifierNCT03174522
SponsorIxaka Ltd
Last Modified on29 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 to 85 years
Diagnosis of Type I or II DM, established more than one year ago
Glycosylated hemoglobin (HbA1c) < 9%
Subjects with poor or no (surgical or endovascular) revascularization option classified as CLI Rutherford Category 5. For these patients, one of the following must be confirmed and documented at screening
Ankle systolic pressure < 70 mmHg, or
Toe systolic pressure < 50 mmHg, or
TcpO2 < 30 mmHg (lying down). Subjects with non-compressible or calcified vessels must qualify on toe pressure or tcpO2
Poor or no revascularization option means that, in the opinion of the
Investigator, revascularization using surgical or endovascular methods are not
feasible due to for example the anatomy of existing vessels and/or existing
comorbidity and/or previously failed surgical or endovascular
revascularization
\. In the opinion of the Investigator, the subject is controlled on medical
therapy indicated for CLI (unless there is a documented contraindication or
intolerance) and pain management is optimized
\. Women of childbearing potential must have a negative pregnancy test at
screening. A woman is considered of childbearing potential, i.e. fertile
following menarche and until becoming post-menopausal unless permanently
sterile. Permanent sterilisation methods include hysterectomy, bilateral
salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as
no menses for 12 months without an alternative medical cause. Men and women
who are sexually active shall use effective contraceptive methods for the
duration of their participation in this study if the partner of the male
participant, or if the female participant is of childbearing potential
Effective contraceptive methods are e.g
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomised partner, or
Sexual abstinence. The use of this contraceptive method should be continued for at least the duration of participation in the study, and should be continued thereafter as long as indicated by the study doctor

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in the
trial
Advanced CLI defined as presence of major tissue loss as significant ulceration/gangrene proximal to the metatarsal heads (CLI Rutherford Category 6). Significant ulceration/gangrene means any ulceration that extends beyond the subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the metatarsal heads
CLI Rutherford Category 4
Uncontrolled or untreated proliferative retinopathy
Failed surgical or endovascular revascularization on the index leg within 10 days after the procedure
Subjects in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory or non-atherosclerotic disorder (e.g., thromboangiitis obliterans (Buerger's Disease), systemic sclerosis (both limited and diffuse forms)
Clinical evidence of invasive infection on index leg defined as major tissue loss at the mid-foot or heel involving tendon and/or bone, and/or when intravenous antibiotics are required to treat the infection according to the Investigator
At screening, the presence of only neuropathic ulcers on the index leg
Amputation at or above the talus on the index leg
Planned major amputation within the first month after randomization
On the index leg, use of concomitant wound treatments not currently approved for ischemic wound-healing within 30 days prior to screening or plans to initiate new, nonstandard-of-care treatments to the index leg during the trial
Blood clotting disorder not caused by medication (e.g., thrombophilia)
Severe hypertension according to the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. (34)
A platelet count < 50,000/L
International normalized ratio (INR) > 1.5. For patients on anticoagulant medication an INR > 1.5 is allowed, provided that the Investigator and the haematologist consider the patient eligible to collect BM
Evidence of moderate to severe hepatocellular dysfunction according to the treating physician
Positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema pallidum
Subjects who may not be healthy enough to successfully complete all protocol requirements including BM collection, or who are not expected to survive more than 12 months, or in whom results may be particularly difficult to assess, as assessed by the Investigator. For example
Concurrent severe congestive heart failure (New York Heart Association Classes III and IV)
Life-threatening ventricular arrhythmias, unstable angina (characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration), and/or myocardial infarction within four weeks before screening
Coronary artery bypass grafting or percutaneous coronary intervention within one month before screening
A renal and/or carotid revascularization procedure within one month of screening
Transient ischemic attack within three months prior to screening
Deep vein thrombosis within three months prior to screening
Subjects with immunocompromised conditions, organ transplant recipients and/or subjects in need of immunosuppressive therapy
Neurological dementia (i.e., Alzheimer's Disease)
Subjects who participate in another clinical interventional trial
Subjects who have been treated with experimental medication within 30 days of screening
Subjects who participated in other cell therapy trials for CLI
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