Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients Wit… (NCT04387825) | Clinical Trial Compass
CompletedPhase 2
Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic Sclerosis
Mexico20 participantsStarted 2015-08-13
Plain-language summary
Systemic sclerosis (SS) causes microvascular alteration in the hand and subsequently pain, skin fibrosis, and osteoarticular deformities. These injuries initiate functional decline of the hand and decrease patient quality of life.
Local application of adipose-derived stromal vascular fraction (ADSVF) has been proposed as an emerging treatment. There are reports about the good results obtained after ADSVF treatment in this kind of patients. For these reasons , we aimed to evaluate the safety and clinical effect of application of fat micrografts enriched with ADSVF to the hands of patients with SS.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with SS, according to the criteria of the American College of Rheumatology and those of LeRoy-Medsger.
* Over 18 years old,
* BMI\> 18 kg / m2.
* Patients received stable vasoactive and immunosuppressive therapies, for at least 1 month before being enrolled in the study, and this was continued unchanged throughout the study.
Exclusion Criteria:
* infected digital ulcers
* comorbidities that could affect hand function
* alcoholism
* drug abuse
* history of family cancer
* Patients with hyperbaric therapy one month before
* Botulinum toxin one month before
* surgical sympathectomy one month before
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain before the treatment and every day during one week after the treatment, and each 28 days after de first week until the 168 day
Timeframe: 168 days
2
Frequency of Raynaud Phenomenon
Timeframe: 168 days
3
Duration of Raynaud Phenomenon
Timeframe: 168 days
Trial details
NCT IDNCT04387825
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran