Mitochondrial MyopathiesPhase 2NCT05962333
Effect and Safety MABs Administration m.3243A>G Mutation Carriers
A Phase 2 study testing Intra-arterial delivery of autologous MABs in people with Mitochondrial Myopathies, run by Maastricht University at 1 site in Netherlands.
Trial summary
The first primary objective is to assess the effect of three intra-arterial administrations of autologous mesoangioblasts (MABs) with respect to improving muscle strength and reduce fatigue of the treated biceps brachii (BB) compared to the untreated BB. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Mitochondrial Myopathies
- What is being tested?
- Intra-arterial delivery of autologous MABs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2023to 1 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent
- Age: 18-64
- 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
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
Show all 16Show fewer
- 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 instructions
- A history of strokes with signs of extra-pyramidal or pyramidal syndrome
- Allergy for contrast fluid
- Peripheral signs of ischemia or vasculopathy
- Claustrophobia
- Metal implants
- Any other factor that in the opinion of the investigator excludes the patient from the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, 6229ER
Florence van Tienen, PhD, 0031433882918
About this study
Official title: Assess Effect and Safety of Intra-arterial Autologous Mesoangioblast Administration to the Upper Arm of m.3243A>G Mutation Carriers
The first primary objective is to assess the effect of three intra-arterial administrations of autologous mesoangioblasts (MABs) with respect to improving muscle strength and reduce fatigue of the treated biceps brachii (BB) compared to the untreated BB.
The second primary objective is safety of three intra-arterial administrations of autologous MABs, which the investigators will assess by monitoring (serious) adverse events ((S)AEs), blood flow in left arm pre- and post-intervention, and neurological vital signs during 8h post-intervention observation in the hospital.
Read more
Secondary objectives are to assess changes in muscle mass of the treated and untreated BB muscle, and microscopic changes and m.3243A>G mutation load at tissue level in treated biceps brachii (BB) muscle at baseline and after treatment.
Up to 20 adult m.3243A>G patients will undergo a ~30mg m. biceps brachii muscle biopsy at visit 1. The first six eligible patients will enroll the clinical study based on their m.3243A>G mutation load in skeletal muscle (50-90%) and mesoangioblasts (<10%), and on a decreased BB muscle strength and increased fatigue.
These 6 selected patients will visit the Maastricht University Medical Center for 8 additional times. From each patient, during visit 2 till 9:
- BB muscle biopsies of the left arm will be collected (1x ~130 mg at visit 2 and 1x ~30mg at visit 9)
- MRI of the BB muscles in both arms will be performed (visit 2 and 9).
- Autologous MABs will be injected into the left arm via axillary artery delivery. Angiography will be performed before and after infusion to assess vascular obstructions, and the participant will be monitored in the hospital for 8 hours (visit 4,6,8).
- Tc99m macroaggregated albumin (MAA) is infused to quantify blood flow to the BB muscle (visit 4).
- A bout of maximal eccentric exercise of BB muscles on both sides will be executed at visit 3, 5 and 7.
- BB muscle strength will be assessed using a Biodex dynamometer (visit 3-9)
- venous blood samples will be taken for assessing muscle damage and inflammation markers (visit 3-9), kidney functioning, coagulation and viral screening (visit 1 and 2).
- Conditions
- Mitochondrial Myopathies
- Being tested
- Intra-arterial delivery of autologous MABs
- Keywords
- m.3243A>G, mesoangioblasts
- Medical subject headings
- Mitochondrial Myopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial delivery of autologous MABsBiological
three times intra-arterial administration of autologous mesoangioblasts in biceps brachii of the left arm at 4-6 week interval
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial delivery of autologous MABs | Experimental | Autologous MABs will be injected three times in left arm to treat biceps brachii muscle Receives: Biological: Intra-arterial delivery of autologous MABs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess blood flow in left arm following i.a. arterial delivery of autologous MABs
Assess blood flow in left arm using digital subtraction angiography (DSA) before and directly after MABs administration in week 1, 5 and 10.
Measured: before and directly after each administration in week 1,5 and 10
Assess (serious) adverse events following 3 i.a. deliveries of autologous MABs
Assessment of (serious) adverse events
Measured: 15 weeks
Assess temperature following 3 i.a. deliveries of autologous MABs
Temperature will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1,5 and 10.
Measured: 0,1,2,3,4,6 and 8 hours after each administration.
Assess oxygen saturation following 3 i.a. deliveries of autologous MABs
Oxygen saturation will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1,5 and 10.
Measured: 0,1,2,3,4,6 and 8 hours after each administration.
Muscle strength arm following 3 i.a. deliveries of autologous MABs
Using Medical Research Council (MRC) scale for muscle strength, muscle strength of left arm will be assessed 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10. MRC scale ranges from 0 (no visible contraction) to 5 (normal)).
Measured: 0,1,2,3,4,6 and 8 hours after each administration.
Assess breathing frequency following 3 i.a. deliveries of autologous MABs
Breathing frequency will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10.
Measured: 0,1,2,3,4,6 and 8 hours after each administration.
Assess vital signs following 3 i.a. deliveries of autologous MABs
Heart rate will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10.
Measured: 0,1,2,3,4,6 and 8 hours after each administration.
Assess systolic and diastolic blood pressure following 3 i.a. deliveries of autologous MABs
Systolic and Diastolic blood pressure will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10.
Measured: 0,1,2,3,4,6 and 8 hours after each administration.
Assess Glasgow Coma scale (GCS) score following 3 i.a. deliveries of autologous MABs
Glasgow Coma Scale (GCS) score will be determined 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10. GCS score ranges from 3 to 15, 3 being the worst and 15 being the best score.
Measured: 0,1,2,3,4,6 and 8 hours after each administration.
Assess if pupil size is symmetrical in both eyes following 3 i.a. deliveries of autologous MABs
Pupil size of both eyes will be assessed 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10. If pupil size is not equal, this can indicate disease or trauma.
Measured: 0, 1,2,3,4,6 and 8 hours after each administration.
Assess pupil reaction following 3 i.a. deliveries of autologous MABs
To assess brain functioning, reaction of pupils to light will be determined 0,1,2,3,4,6 and 8 hours after administration. Upon light, both pupils should become smaller in week 1, 5 and 10. No reaction or only reaction in one eye can indicate nerve damage.
Measured: 0,1,2,3,4,6 and 8 hours after each administration.
Assess changes in muscle strength of biceps brachii muscle in both arms at baseline and 4-6 weeks after third i.a. delivery of autologous MABs in left arm, which is 12-16 weeks after baseline measurements.
Determine maximum muscle force generating capacity (peak torque N/m) of the biceps brachii muscle in both arms using Biodex dynamometer measurements. Measurements will be performed in left (intervention) and right (no intervention) biceps brachii muscle using Biodex dynamometer measurements at baseline and 5 weeks after the third autologous MABs administration, which is 15 weeks after baseline measurements.
Measured: baseline and 15 weeks after 1st administration
Assess changes in muscle fatigue of biceps brachii muscle in both arms at baseline and 4-6 weeks after third i.a. delivery of autologous MABs in left arm, which is 12-16 weeks after baseline measurements.
Asses changes in muscle fatigue by measuring percentage decrease in maximum muscle force generating capacity (peak torque N/m) between first and sixth repetition. Measurements will be performed in left (intervention) and right (no intervention) biceps brachii muscle using Biodex dynamometer measurements at baseline and 5 weeks after the third autologous MABs administration, which is 15 weeks after baseline measurements.
Measured: baseline and 15 weeks after 1st administration
Secondary outcomes (4)
Assess changes in muscle volume biceps brachii muscles of both arms following 3 i.a. deliveries of autologous MABs in left arm.
MRI T3 analysis to assess changes in muscle volume in both arms at baseline and 5 weeks after the third autologous MABs administration, which is 15 weeks after baseline measurements.
Measured: baseline and 15 weeks after 1st administration
Assess formation of new muscle fibers following 3 i.a. deliveries of autologous MABs
Perform embryonic myosin heavy chain (MHC)+ immunostaining to assess percentage of new / regenerating muscle fibers in muscle biopsies collected at baseline and 5 weeks after the third autologous MABs administration, which is 15 weeks after baseline measurements.
Measured: baseline and 15 weeks after 1st administration
Mitochondrial mutation load and functioning following 3 i.a. deliveries of autologous MABs
Assess changes in m.3243A>G mutation load in new/regenerating muscle fibers compared to existing muscle fibers isolated via laser microdissection from muscle biopsies left arm collected at baseline and 5 weeks after the third autologous MABs administration, which is 15 weeks after baseline measurements.
Measured: baseline and 15 weeks after 1st administration
Mitochondrial functioning following 3 i.a. deliveries of autologous MABs in left arm.
Assess changes in mitochondrial functioning by performing Cytochrome C Oxidase / Succinate Dehydrogenase (COX/SDH) staining in muscle biopsies from left arm collected at baseline and 5 weeks after the third autologous MABs administration, which is 15 weeks after baseline measurements.
Measured: baseline and 15 weeks after 1st administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitochondrial MyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intra-subjected controlled clinical study. Treatment is performed in left arm of the subjects and right arm (no intervention), measurements are performed before the first and after the last administration.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janneke Hoeijmakers, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962333
- Sponsor's protocol ID
- NL82815.000.22
- Status last verified
- Apr 2024
- First submitted
- 23 May 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Tienen F, Zelissen R, Timmer E, van Gisbergen M, Lindsey P, Quattrocelli M, Sampaolesi M, Mulder-den Hartog E, de Coo I, Smeets H. Healthy, mtDNA-mutation free mesoangioblasts from mtDNA patients qualify for autologous therapy. Stem Cell Res Ther. 2019 Dec 21;10(1):405. doi: 10.1186/s13287-019-1510-8.
PubMed 31864395
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess Effect and Safety of Intra-arterial Autologous Mesoangioblast Administration to the Upper Arm of m.3243A>G Mutation Carriers
- ClinicalTrials.gov ID
- NCT05962333
- Acronym / sponsor ID
- NL82815.000.22
- Conditions
- Mitochondrial Myopathies
- Keywords
- m.3243A>G, mesoangioblasts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first primary objective is to assess the effect of three intra-arterial administrations of autologous mesoangioblasts (MABs) with respect to improving muscle strength and reduce fatigue of the treated biceps brachii (BB) compared to the untreated BB.
The second primary objective is safety of three intra-arterial administrations of autologous MABs, which the investigators will assess by monitoring (serious) adverse events ((S)AEs), blood flow in left arm pre- and post-intervention, and neurological vital signs during 8h post-intervention observation in the hospital.
Secondary objectives are to assess changes in muscle mass of the treated and untreated BB muscle, and microscopic changes and m.3243A>G mutation load at tissue level in treated biceps brachii (BB) muscle at baseline and after treatment.
Up to 20 adult m.3243A>G patients will undergo a ~30mg m. biceps brachii muscle biopsy at visit 1. The first six eligible patients will enroll the clinical study based on their m.3243A>G mutation load in skeletal muscle (50-90%) and mesoangioblasts (<10%), and on a decreased BB muscle strength and increased fatigue.
These 6 selected patients will visit the Maastricht University Medical Center for 8 additional times. From each patient, during visit 2 till 9:
- BB muscle biopsies of the left arm will be collected (1x ~130 mg at visit 2 and 1x ~30mg at visit 9)
- MRI of the BB muscles in both arms will be performed (visit 2 and 9).
- Autologous MABs will be injected into the left arm via axillary artery delivery. Angiography will be performed before and after infusion to assess vascular obstructions, and the participant will be monitored in the hospital for 8 hours (visit 4,6,8).
- Tc99m macroaggregated albumin (MAA) is infused to quantify blood flow to the BB muscle (visit 4).
- A bout of maximal eccentric exercise of BB muscles on both sides will be executed at visit 3, 5 and 7.
- BB muscle strength will be assessed using a Biodex dynamometer (visit 3-9)
- venous blood samples will be taken for assessing muscle damage and inflammation markers (visit 3-9), kidney functioning, coagulation and viral screening (visit 1 and 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-subjected controlled clinical study. Treatment is performed in left arm of the subjects and right arm (no intervention), measurements are performed before the first and after the last administration.
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial delivery of autologous MABs | Experimental | Biological: Intra-arterial delivery of autologous MABsAutologous MABs will be injected three times in left arm to treat biceps brachii muscle |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent
- Age: 18-64
- 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
Key exclusion criteria (16 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-arterial delivery of autologous MABsthree times intra-arterial administration of autologous mesoangioblasts in biceps brachii of the left arm at 4-6 week interval | Biological | Intra-arterial delivery of autologous MABs |
Primary outcome
Assess blood flow in left arm following i.a. arterial delivery of autologous MABs
Time frame: before and directly after each administration in week 1,5 and 10
Assess blood flow in left arm using digital subtraction angiography (DSA) before and directly after MABs administration in week 1, 5 and 10.
Assess (serious) adverse events following 3 i.a. deliveries of autologous MABs
Time frame: 15 weeks
Assessment of (serious) adverse events
Assess temperature following 3 i.a. deliveries of autologous MABs
Time frame: 0,1,2,3,4,6 and 8 hours after each administration.
Temperature will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1,5 and 10.
Assess oxygen saturation following 3 i.a. deliveries of autologous MABs
Time frame: 0,1,2,3,4,6 and 8 hours after each administration.
Oxygen saturation will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1,5 and 10.
Muscle strength arm following 3 i.a. deliveries of autologous MABs
Time frame: 0,1,2,3,4,6 and 8 hours after each administration.
Using Medical Research Council (MRC) scale for muscle strength, muscle strength of left arm will be assessed 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10. MRC scale ranges from 0 (no visible contraction) to 5 (normal)).
Assess breathing frequency following 3 i.a. deliveries of autologous MABs
Time frame: 0,1,2,3,4,6 and 8 hours after each administration.
Breathing frequency will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10.
Assess vital signs following 3 i.a. deliveries of autologous MABs
Time frame: 0,1,2,3,4,6 and 8 hours after each administration.
Heart rate will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10.
Assess systolic and diastolic blood pressure following 3 i.a. deliveries of autologous MABs
Time frame: 0,1,2,3,4,6 and 8 hours after each administration.
Systolic and Diastolic blood pressure will be checked 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10.
Assess Glasgow Coma scale (GCS) score following 3 i.a. deliveries of autologous MABs
Time frame: 0,1,2,3,4,6 and 8 hours after each administration.
Glasgow Coma Scale (GCS) score will be determined 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10. GCS score ranges from 3 to 15, 3 being the worst and 15 being the best score.
Assess if pupil size is symmetrical in both eyes following 3 i.a. deliveries of autologous MABs
Time frame: 0, 1,2,3,4,6 and 8 hours after each administration.
Pupil size of both eyes will be assessed 0,1,2,3,4,6 and 8 hours after administration in week 1, 5 and 10. If pupil size is not equal, this can indicate disease or trauma.
Assess pupil reaction following 3 i.a. deliveries of autologous MABs
Time frame: 0,1,2,3,4,6 and 8 hours after each administration.
To assess brain functioning, reaction of pupils to light will be determined 0,1,2,3,4,6 and 8 hours after administration. Upon light, both pupils should become smaller in week 1, 5 and 10. No reaction or only reaction in one eye can indicate nerve damage.
Assess changes in muscle strength of biceps brachii muscle in both arms at baseline and 4-6 weeks after third i.a. delivery of autologous MABs in left arm, which is 12-16 weeks after baseline measurements.
Time frame: baseline and 15 weeks after 1st administration
Determine maximum muscle force generating capacity (peak torque N/m) of the biceps brachii muscle in both arms using Biodex dynamometer measurements. Measurements will be performed in left (intervention) and right (no intervention) biceps brachii muscle using Biodex dynamometer measurements at baseline and 5 weeks after the third autologous MABs administration, which is 15 weeks after baseline measurements.
Assess changes in muscle fatigue of biceps brachii muscle in both arms at baseline and 4-6 weeks after third i.a. delivery of autologous MABs in left arm, which is 12-16 weeks after baseline measurements.
Time frame: baseline and 15 weeks after 1st administration
Asses changes in muscle fatigue by measuring percentage decrease in maximum muscle force generating capacity (peak torque N/m) between first and sixth repetition. Measurements will be performed in left (intervention) and right (no intervention) biceps brachii muscle using Biodex dynamometer measurements at baseline and 5 weeks after the third autologous MABs administration, which is 15 weeks after baseline measurements.
4 secondary outcomes
Assess changes in muscle volume biceps brachii muscles of both arms following 3 i.a. deliveries of autologous MABs in left arm.
Time frame: baseline and 15 weeks after 1st administration
Assess formation of new muscle fibers following 3 i.a. deliveries of autologous MABs
Time frame: baseline and 15 weeks after 1st administration
Mitochondrial mutation load and functioning following 3 i.a. deliveries of autologous MABs
Time frame: baseline and 15 weeks after 1st administration
Mitochondrial functioning following 3 i.a. deliveries of autologous MABs in left arm.
Time frame: baseline and 15 weeks after 1st administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Results publication: PubMed 31864395van Tienen F, Zelissen R, Timmer E, van Gisbergen M, Lindsey P, Quattrocelli M, Sampaolesi M, Mulder-den Hartog E, de Coo I, Smeets H. Healthy, mtDNA-mutation free mesoangioblasts from mtDNA patients qualify for autologous therapy. Stem Cell Res Ther. 2019 Dec 21;10(1):405. doi: 10.1186/s13287-019-1510-8.
- website Generate Your Muscle (GYM) projectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janneke Hoeijmakers, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intra-arterial delivery of autologous MABs in people with Mitochondrial Myopathies, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence van Tienen, PhD (00314331995, florence.vantienen@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess blood flow in left arm following i.a. arterial delivery of autologous MABs (time frame: before and directly after each administration in week 1,5 and 10). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.