Safety Of Fat Micrografts With Adipose-Derived Stromal Vascular Fraction In Hands Of Patients With Systemic Sclerosis

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase: Completed; Phase 2

Conditions: Systemic Sclerosis

Treatments: Drug: ADSVF application in the right hand

Study type: Interventional

Funder types: Other

Identifiers

NCT04387825

SCI-1505-15/15-1

290250 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Drug: ADSVF application in the right hand

Control

No Intervention group

Description:

Evolution and medical therapy effects were observed in the control group.