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Clinical Trials/EUCTR2016-000240-34-NL
EUCTR2016-000240-34-NL
Active, not recruiting
Phase 1

The Efficacy and Safety of Intra-Arterial Administration of Rexmyelocel T to treat Critical Limb Ischemia in Subjects with Diabetes Mellitus: Two Pivotal, Placebo Controlled, Double-Blind, Parallel-Group, Adaptive Trials

Rexgenero Limited0 sites60 target enrollmentFebruary 8, 2017
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ConditionsCritical Limb Ischemia in patients with Diabetes MellitusMedDRA version: 19.1Level: LLTClassification code 10077142Term: Limb ischemiaSystem Organ Class: 100000004866MedDRA version: 19.1Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866MedDRA version: 19.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Critical Limb Ischemia in patients with Diabetes Mellitus
Sponsor
Rexgenero Limited
Enrollment
60
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 8, 2017
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Rexgenero Limited

Eligibility Criteria

Inclusion Criteria

  • •To be eligible for this trial subjects must satisfy all of the following criteria:
  • •1\. Aged \= 18 to \= 85 years.
  • •2\. Diagnosis of Type I or II DM, established more than one year ago.
  • •3\. Glycosylated hemoglobin (HbA1c) \< 9%.
  • •4\. Subjects with poor or no (surgical or endovascular) revascularization option classified as CLI Rutherford Category 4\.
  • •These subjects must have documentation of severely compromised hemodynamics at screening defined as:
  • •Ankle systolic pressure \< 50 mm Hg, or
  • •Toe systolic pressure \< 30 mm Hg, or
  • •TcpO2 \< 30 mm Hg, and
  • •Flat or barely pulsatile ankle or metatarsal PVR

Exclusion Criteria

  • •Subjects meeting any of the following criteria must not be enrolled in the trial:
  • •1\. 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.
  • •2\. CLI Rutherford Category 5\.
  • •3\. Uncontrolled or untreated proliferative retinopathy.
  • •4\. Failed surgical or endovascular revascularization on the index leg within 10 days after the procedure.
  • •5\. 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).
  • •6\. 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.
  • •7\. At screening, the presence of only neuropathic ulcers on the index leg.
  • •8\. Amputation at or above the talus on the index leg.
  • •9\. Planned major amputation within the first month after randomization.

Outcomes

Primary Outcomes

Not specified

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