Skip to main content
Clinical Trials/NL-OMON55910
NL-OMON55910
Not yet recruiting
Phase 2

Assess effect and safety of intra-arterial autologous mesoangioblasts administration to the upper arm of m.3243A>G mutation carriers - Effect and safety MABs administration m.3243A>G carriers

Medisch Universitair Ziekenhuis Maastricht0 sites20 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Medisch Universitair Ziekenhuis Maastricht
Enrollment
20
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Medisch Universitair Ziekenhuis Maastricht

Eligibility Criteria

Inclusion Criteria

  • \- Written informed consent \- Age: 18\-64 year \- Sex: male/female \- Patients with
  • the m.3243A\>G mutation load of 50%\-90% determined in skeletal muscle or derived
  • from age\-corrected calculation of blood m.3243A\>G mutation load

Exclusion Criteria

  • \- Use of dabigatran, apixaban, edoxaban or rivaroxaban (DOACs) as
  • anti\-coagulants
  • \- Have a weekly alcohol intake of \>\= 35 units (men) or \>\= 24 units (women)
  • \- Current history of drug abuse
  • \- Deficient immune system or autoimmune disease
  • \- Significant concurrent illness
  • \- Ongoing participation in other clinical trials with intervention
  • \- Pregnant or lactating women
  • \- Psychiatric or other disorders likely to impact on informed consent
  • \- Patients unable and/or unwilling to comply with treatment and study

Outcomes

Primary Outcomes

Not specified

Similar Trials

Withdrawn
Phase 3
The Efficacy and Safety of Intra-Arterial Administration of REX-001 to treat ischaemic rest pain in Subjects with Critical Limb Ischaemia Rutherford Category 4 and Diabetes Mellitus: A Pivotal, Placebo Controlled, Double-Blind, Parallel-Group, Adaptive Trialperipheral artery diseaserest pain in legs and feet10047066
NL-OMON47803Rexgenero Limited6
Active, not recruiting
Phase 1
A clinical trial to test the efficacy and safety of intra-arterial administration of REX-001 to treat ischemic ulcers in subjects with critical limb ischaemia Rutherford Category 5 and diabetes mellitus.Critical Limb Ischemia in patients with Diabetes MellitusMedDRA version: 21.1 Level: LLT Classification code 10077142 Term: Limb ischemia System Organ Class: 100000004866MedDRA version: 21.1 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 100000004866MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2016-003980-21-HURexgenero Limited78
Active, not recruiting
Phase 1
A clinical trial to test the efficacy and safety of a bone marrow cell preparation to treat Critical Limb Ischemia in Subjects with Diabetes Mellitus.Critical 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]
EUCTR2016-000240-34-NLRexgenero Limited60
Active, not recruiting
Phase 1
A clinical trial to test the efficacy and safety of intra-arterial administration of REX-001 to treat ischaemic ulcers in subjects with Critical Limb Ischaemia Rutherford Category 5 and Diabetes Mellitus.Critical Limb Ischemia in patients with Diabetes MellitusMedDRA version: 21.1Level: LLTClassification code 10077142Term: Limb ischemiaSystem Organ Class: 100000004866MedDRA version: 24.0Level: LLTClassification code 10058069Term: Critical limb ischemiaSystem Organ Class: 100000004866MedDRA version: 20.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2016-003980-21-PTRexgenero Limited78
Active, not recruiting
Phase 1
A clinical trial to test the efficacy and safety of a bone marrow cell preparation to treat Critical Limb Ischemia in Subjects with Diabetes Mellitus.Critical Limb Ischemia in patients with Diabetes MellitusMedDRA version: 21.1 Level: LLT Classification code 10077142 Term: Limb ischemia System Organ Class: 100000004866MedDRA version: 21.1 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 100000004866MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2016-000240-34-PTRexgenero Limited60