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A Study of CYP-001 for the Treatment of Steroid-Resistant Acute Graft Versus Host Disease

NCT02923375 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-08-11

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability and efficacy of two infusions of CYP-001 in adults with steroid-resistant GvHD.

Conditions

  • Graft vs Host Disease

Interventions

BIOLOGICAL

Mesenchymoangioblast-derived mesenchymal stem cells

The active agent in CYP-001 is allogeneic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs), which are produced using the proprietary Cymerus™ platform technology. Cymerus™ refers to the process of generating cell-based products from intermediate cells, MCAs, which in turn are derived from induced pluripotent stem cells or iPSCs. The iPSCs used in the Cymerus™ process were derived from blood donated by a fully-consented healthy adult donor, and were reprogrammed using a transgene-free, viral-free and feeder-free technique.

Sponsors & Collaborators

  • Cynata Therapeutics Limited

    lead INDUSTRY

Principal Investigators

  • Kilian Kelly, PhD · Cynata Therapeutics Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-08-28
Completion
2020-06-30
FDA Drug
Yes

Countries

  • Australia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02923375 on ClinicalTrials.gov