Overview
Sponsor-declared trial summary
diabetic foot syndrome
The aim of the project is to compare the effect on tissue oxygenation and clinical outcome of autologous cell therapy with standard treatment in patients with chronic limb-threatening ischemia (CLTI) and diabetic foot ulcers (DFU) not eligible for PTA and to verify the effect of repetitive cell therapy.
Key facts
- Sponsor
- Institute For Clinical And Experimental Medicine
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 11 Sep 2020 → ongoing
- Decision date (initial)
- 2025-01-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Institute For Clinical And Experimental Medicine
External identifiers
- EU CT number
- 2024-519687-40-00
- EudraCT number
- 2020-002540-23
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
The aim of the project is to compare the effect on tissue oxygenation and clinical outcome of autologous cell therapy with standard treatment in patients with chronic limb-threatening ischemia (CLTI) and diabetic foot ulcers (DFU) not eligible for PTA and to verify the effect of repetitive cell therapy.
Secondary objectives 1
- Other objectives of the project are quality of life assessment and side effects of study treatment.
Conditions and MedDRA coding
diabetic foot syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- diabetic foot ulcers (DFU; ulcer distal from ankle) or status after minor amputation, in accordance with international classification TEXAS 2C-3D, Wagner 2-4 or ischemic rest pain
- presence of chronic limb-threatening ischemia attributable to objectively proven arterial occlusive disease; (TcPO2) under 40 mm Hg, indication for PTA
- age 18-90 years
- diabetes mellitus type 1 or 2
- signed informed consent
Exclusion criteria 10
- severe active deep infection of DFU
- deep vein thrombosis less than 6 months
- severe limb oedema that rule out intramuscular injection of cell suspension
- severe non-treated diabetic retinopathy requiring acutely a laser therapy
- severe haematological disease
- diagnosed neoplastic process of any organ less than 5 years
- expected life prognosis shorter than 6 months
- contracindication of general anestesia
- females of childbearing potential must be willing to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.
- pregnant women – the test of pregnancy is the part of the examination before inclusion into the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Comparison of cell therapy with standard treatment in several parameters: Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods)
- Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival
Secondary endpoints 3
- Safety: adverse events - expected and unexpected
- Assesment of study treatment by patients (psychological questionaries)
- To assess the relation between the quality of cell suspension and tissue oxygenation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Suspension of autologous mononuclear cells separated from bone marrow aspirate
PRD11759128 · Product
- Active substance
- Autologous Bone Marrow-Derived Mononuclear Cells
- Substance synonyms
- REXMYELOCEL-T, REX-001
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 60 ml millilitre(s)
- Max total dose
- 60 ml millilitre(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institute For Clinical And Experimental Medicine
- Sponsor organisation
- Institute For Clinical And Experimental Medicine
- Address
- Videnska 1958/9, Krc Krc
- City
- Prague
- Postcode
- 140 00
- Country
- Czechia
Scientific contact point
- Organisation
- Institute For Clinical And Experimental Medicine
- Contact name
- Michal Dubský
Public contact point
- Organisation
- Institute For Clinical And Experimental Medicine
- Contact name
- Michal Dubský
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2020-09-11 | 2020-09-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protokol | 1.1 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | KH_Informovany_souhlas | 1.0 |
| Synopsis of the protocol (for publication) | Souhrn_protokolu | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-28 | Czechia | Acceptable 2025-01-10
|
2025-01-13 |