Overview
Sponsor-declared trial summary
chronic limb-threatening ischemia
The aim of the clinical trial is to compare the effect of the combination of cell therapy and PTA with the effect of PTA alone and to assess possible side effects and complications of both methods. Primary: rate of major amputation, wound healing, TcPO2.
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]
- Decision date (initial)
- 2025-02-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Institute For Clinical And Experimental Medicine · Agentura pro zdravotnický výzkum České republiky
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
The aim of the clinical trial is to compare the effect of the combination of cell therapy and PTA with the effect of PTA alone and to assess possible side effects and complications of both methods.
Primary: rate of major amputation, wound healing, TcPO2.
Conditions and MedDRA coding
chronic limb-threatening ischemia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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.
- females of childbearing potential must be willing for the duration of the study 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.
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
- pregnant women – the test of pregnancy is the part of the examination before inclusion into the study
- breastfeeding women and women planning pregnancy at the time of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- rate of major amputation, wound healing, TcPO2
Secondary endpoints 4
- other ischemia parameteres – ABI, laser doppler flowmetry, magnetic resonance spectroscopy; optional: microbiopsy of the muscle of the foot
- other clinical effect – pain
- safety: adverse events – expected and unexpected
- assessment of quality of life (standardized questionnaires)
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
- 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 | Authorised, recruitment pending | 110 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 36_BODOVY KRATKY DOTAZNIK ZDRAVI_SF_36 | 1 |
| Protocol (for publication) | BMMNC_PTA_Protocol | 2.0 |
| Protocol (for publication) | Dotaznik EQ_5D_5L | 1 |
| Protocol (for publication) | Dotaznik subjektivniho vnimani bolesti | 1 |
| Recruitment arrangements (for publication) | Sablona c 1_Recuitment arrangements | 1 |
| Subject information and informed consent form (for publication) | BMMNC_PTA_IS_pacient | 1.1 |
| Synopsis of the protocol (for publication) | BMMNC_PTA_003_Souhrn_protokolu_CZ | 2.0 |
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 2025-02-24
|
2025-02-25 |