SVF: Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions

Sponsor

Dubai Health Authority (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06000670

Collaborator

(none)

300

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

clinical efficacy of autologous stromal vascular fraction SVF,for inflammatory and degenerative conditions of the knees

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: stromal vascular fraction injection in the osteoarthritic knee	N/A

Detailed Description

to evaluate the clinical effectiveness of point of care autologous adipose derived stromal vascular fraction (SVF) alone or in combination with exosomes,for inflammatory and degenerative conditions of the knees.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

investigator is blinded to clinical and radiological assessments .

Primary Purpose:

Other

Official Title:

Efficacy of Autologous Adipose Derived Stromal Vascular Fraction for Musculoskeletal Conditions

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: knee osteoarhritis patients with grade 2 and above chondromlacia as well as all grades of osteoarhtritis	Procedure: stromal vascular fraction injection in the osteoarthritic knee stromal vascular fraction harvested from mid abdominal wall under sedation and seperated from fat using mechanical centrifugation .injection of 5 cc of the SVF in the affected knee.

Arm

Intervention/Treatment

Experimental: knee osteoarhritis

patients with grade 2 and above chondromlacia as well as all grades of osteoarhtritis

Procedure: stromal vascular fraction injection in the osteoarthritic knee

stromal vascular fraction harvested from mid abdominal wall under sedation and seperated from fat using mechanical centrifugation .injection of 5 cc of the SVF in the affected knee.

Outcome Measures

Primary Outcome Measures

change in pain level [2 years]
visual analog scale 0-10 ( 10 being worst)

Secondary Outcome Measures

percentage cartilage thickness change [2 years]
as measured by MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

knee osteoarthritis any grade
knee chondromalacia grade 2 and above

Exclusion Criteria:

active HIV
pregnant women
Mental disease
severe cardio vascular disease
severe coagulation disorders
infected tissues
patients on other experimental studies within 3 months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dubai Health Authority

Investigators

Study Director: DHA DHA, dubai health autority

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

cell surgical network

Publications

None provided.

Responsible Party:

Amer Mansour, consultant orthopedic surgeon, Dubai Health Authority

ClinicalTrials.gov Identifier:

NCT06000670

Other Study ID Numbers:

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Amer Mansour, consultant orthopedic surgeon, Dubai Health Authority

knee osteoarthritis

knee chondromalacia

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Aug 21, 2023