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

NCT04387825 | Completed Phase 2 DMC

• 2 other identifiers: SCI-1505-15/15-1290250
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Sclerosis

Keywords

Hand deformities in Systemic sclerosis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  168 days

• Frequency of Raynaud Phenomenon

  Frequency, number of events per day/week;

  168 days

• Duration of Raynaud Phenomenon

  Duration of minutes in every event.

  168 days

Secondary Outcomes (8)

• Digital Total active Motion

  168 days

• Digital oximetry

  168 days

• Digital Ulcers

  168 days

• Health status and disability index

  168 days

• Hand Function

  168 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: ADSVF application in the right hand

Control

NO INTERVENTION

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

Interventions

ADSVF application in the right hand DRUG

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

Also known as: Medical treatment

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion salvador Zubiran

México, 14080, Mexico

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Carlos Hinojosa, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon

Model Details: 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

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 14, 2020
• Study Start: August 13, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)