CYP-CLI-P2-01: CYP-002 in Adults with Critical Limb Ischaemia

• Research type

  Research Study

• Full title

  A Randomised, Double-blind, Placebo-controlled Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of CYP-002 in Adults with Critical Limb Ischaemia who are Unsuitable for Revascularisation

• IRAS ID

  275688

• Contact name

  Dr. Sheikh Tawqeer Rashid

• Contact email

  Tawqeer.rashid@mft.nhs.uk

• Sponsor organisation

  Cynata Therapeutics Limited

• Eudract number

  2019-001361-33

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  Summary of Research

  This clinical research study is looking at patients with critical limb ischaemia (CLI). CLI is an advanced stage of peripheral artery disease (PAD), which is an impaired or reduced blood flow to the lower limbs due to a narrowing of the blood vessels. This can lead to a high risk of limb loss, heart attack and stroke. Current treatments for PAD/CLI include lifestyle changes, medications, procedures to increase blood flow to the lower limbs (called revascularisation) or amputation. These treatments do not always work well enough to stop the disease from getting worse or to cure the disease.

  The main purpose of this study is to test a new treatment called CYP-002. The study will look at whether CYP-002 works in patients with CLI, how safe CYP-002 is and whether the body can handle it.

  CYP-002 is made of mesenchymal stem cells (MSCs) . Stem cells are cells that can turn into other types of cells and may help the body in its own ability to repair or replace tissue that has been damaged or destroyed by injury or disease.

  In this study, 2 different doses of CYP-002 will be compared with a placebo. A placebo looks like CYP-002 but will not contain any MSCs. You will be randomly assigned (by a computer) and will have an equal chance of being in one of the following treatment groups:
  • Group A: Low dose of CYP-002
  • Group B: High dose of CYP-002
  • Group C: Placebo

  Each treatment group will have 30 participants. Out of every three people, two will receive CYP-002 and one will receive placebo.

  Study participation will last for approximately 2 years and will involve up to 9 visits to the study centre. These visits will consist of a screening visit, a treatment visit, and 7 follow-up visits.

  Summary of Results

  The trial of CYP-002 in adults with critical limb ischaemia received Ethic Committee approval on 27 July 2020 and was subsequently put on hold by the sponsor during COVID-19 restrictions. The study was terminated for commercial reasons on 22 November 2021. No participants were recruited to the study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  20/SC/0196

• Date of REC Opinion

  27 Jul 2020

• REC opinion

  Further Information Favourable Opinion