Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic Sclerosis
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| ClinicalTrials.gov Identifier: NCT04387825 |
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Recruitment Status :
Completed
First Posted : May 14, 2020
Last Update Posted : May 15, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Systemic Sclerosis | Drug: ADSVF application in the right hand | Phase 2 |
The regenerative properties of adipose stem cells (ASCs) existing in the mixed cell fraction obtained by enzymatic digestion of adipose tissue, termed adipose-derived stromal vascular fraction (ADSVF), were initially described in 2002. These cells have the characteristics of being multipotent and exerting local angiogenic, anti-inflammatory, antifibrotic, immunomodulatory, and regenerative effects after application. ASCs express their angiogenic properties most effectively in a hypoxic environment.
For the above reasons, and because of its abundance in fat, easy acquisition, and almost immediate availability for use, ADSVF has positioned itself as an alternative for repair and regeneration of ischemic tissue.
Application of decanted fat, centrifuged fat, and ADSVF, has consistently and significantly improved pain, Raynaund Phenomen, and healing of digital ulcers in the hands of patients with SS, and thus improved their quality of life. Other inconsistent benefits have also been reported, such as decreased digital circumference, improvement in digital mobility and strength, improvement in formation of new subungual capillaries, and improvement in function through evaluation of the Cochin scale.
Based on the above findings, and because changes in the hands of patients with SS may arise through loss of adipocytes and defective stem cell function, we designed the present study with the aim of evaluating the safety, reproducibility, and clinical effects of application of fat micrografts enriched with ADSVF to the hands of patients affected with SS in a controlled clinical trial.
The experimental and control groups each contained 10 patients diagnosed with SS according to the criteria of the American College of Rheumatology and the LeRoy-Medsger criteria.
It was decided to carry out the treatment on the most affected hand of the patients, which was the right hand in the entire experimental group. ADSVF-enriched fat micrografts were applied to the experimental group. Evolution and medical therapy effects were observed in the control group.
The fat was obtained by liposucction and the ADSVF was processed in laboratory.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Adipose Derived Stromal Vascular Fraction (ADSVF) was obtained in a laboratory by enzymatic digestion of fat graft harvested by liposuction. This ADSVF and micro fat grafts were applied into the hands with fibrosis and digital ulcers caused by Systemic Sclerosis in the experimental group. The control group was treated with medical treatment only |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Lipograft Safety Enriched With Vascular Stromal Fraction Derived From Adipose Tissue, to Treatment of Digital Joint Fibrosis and Refractory Ischemic Digital Ulcers Caused by Systemic Sclerosis |
| Actual Study Start Date : | August 13, 2015 |
| Actual Primary Completion Date : | May 2019 |
| Actual Study Completion Date : | May 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental group
40 ml of fat was mixed with 2 ml of ADSVF and placed in 1-ml and 3-ml syringes. Using a 19-gauge blunt cannula (0.8 mm), 0.5 ml was applied to the radial and ulnar edge of each metacarpal phalangeal (MP) and interphalangeal (IP) joint in contact with each neurovascular digital pedicle and 3 ml was applied to each side of the metacarpal trapezius joint, together with 10 ml distributed subcutaneously throughout the palm of the hand and 10 ml evenly distributed on the back of the hand
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Drug: ADSVF application in the right hand
40 ml of fat was mixed with 2 ml of ADSVF and placed in 1-ml and 3-ml syringes. Using a 19-gauge blunt cannula (0.8 mm), 0.5 ml was applied to the radial and ulnar edge of each metacarpal phalangeal (MP) and interphalangeal (IP) joint in contact with each neurovascular digital pedicle and 3 ml was applied to each side of the metacarpal trapezius joint, together with 10 ml distributed subcutaneously throughout the palm of the hand and 10 ml evenly distributed on the back of the hand
Other Name: Medical treatment |
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No Intervention: Control
Evolution and medical therapy effects were observed in the control group.
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- 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 [ Time Frame: 168 days ]Evaluation with Numerical Pain Rating Scale(NPRS) before, and after the intervention. The minimum value is 0 and maximum is 10. High value is worst
- Frequency of Raynaud Phenomenon [ Time Frame: 168 days ]Frequency, number of events per day/week;
- Duration of Raynaud Phenomenon [ Time Frame: 168 days ]Duration of minutes in every event.
- Digital Total active Motion [ Time Frame: 168 days ]Goniometry, kapandjy Test
- Digital oximetry [ Time Frame: 168 days ]Transcutaneous Oximetry
- Digital Ulcers [ Time Frame: 168 days ]Number of ulcers
- Health status and disability index [ Time Frame: 168 days ]Evaluated by Sclerosis Health assessment Questionnarie (SHAQ) scale, before and at the end of the study. The value are from 0 to 3. A result >1.25 is worst
- Hand Function [ Time Frame: 168 days ]Cochin Scale, the values are from 0 to 90, higher values means poor function
- Health-related quality of life, before de treatment and at the end of the study [ Time Frame: 168 days ]Short Form 36 (SF-36) scale. High values is poor patient health
- Vascularity of the nail bed [ Time Frame: 168 days ]Videocapillaroscopy by field
- Skin affection of the hand [ Time Frame: 168 days ]Modified Rodnan scale, the values are from 0 to 51. High values higher skin fibrosis
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387825
| Mexico | |
| Instituto Nacional de Ciencias Medicas y Nutricion salvador Zubiran | |
| Mexico, Mexico, 14080 | |
| Study Chair: | Carlos Hinojosa, MD | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| Responsible Party: | Martín Iglesias, Plastic Surgeon, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| ClinicalTrials.gov Identifier: | NCT04387825 |
| Other Study ID Numbers: |
SCI-1505-15/15-1 290250 ( Other Grant/Funding Number: CONACYT ) |
| First Posted: | May 14, 2020 Key Record Dates |
| Last Update Posted: | May 15, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Hand deformities in Systemic sclerosis |
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Scleroderma, Systemic Scleroderma, Diffuse Sclerosis |
Pathologic Processes Connective Tissue Diseases Skin Diseases |