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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04238143




Registration number
NCT04238143
Ethics application status
Date submitted
13/01/2020
Date registered
23/01/2020

Titles & IDs
Public title
Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis
Scientific title
Adipose-Derived Biocellular Regenerative Therapy in Treatment of Osteoarthritis (OA) and Associated Connective Tissue Degeneration and Pain
Secondary ID [1] 0 0
GARM-MSK-ALD
Universal Trial Number (UTN)
Trial acronym
GARM-MSK-ALD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Osteo Arthritis Knee 0 0
Osteo Arthritis Shoulders 0 0
Osteoarthritis of Multiple Joints 0 0
Osteoarthritis, Hip 0 0
Osteoarthritis - Ankle/Foot 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Tissue Stromal Vascular Fraction (tSVF) Arm 1
Treatment: Other - PRP Concentrate Arm 1
Treatment: Surgery - Tissue Stromal Vascular Fraction (tSVF) Arm 2
Treatment: Other - PRP Concentrate Arm 2
Treatment: Surgery - Cellular Stromal Vascular Fraction (cSVF) Arm 2
Treatment: Surgery - Cellular Stromal Vascular Fraction (cSVF) Arm 3
Treatment: Drugs - Sterile Normal Saline (IV Solution)

Experimental: tSVF + PRP Arm1 - Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate

Experimental: tSVF + PRP + cSVF Arm 2 - Tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) Concentrate + Cellular Stromal Vascular Fraction (cSVF)

Experimental: Normal Saline IV + cSVF Arm 3 - Cellular Stromal Vascular Fraction (cSVF); Sterile Normal Saline Intravenous (IV) Introduction


Treatment: Surgery: Tissue Stromal Vascular Fraction (tSVF) Arm 1
Harvesting subcutaneous tSVF with sterile, disposable microcannula system

Treatment: Other: PRP Concentrate Arm 1
Preparation of PRP Concentrate via sterile Terumo-Harvest System

Treatment: Surgery: Tissue Stromal Vascular Fraction (tSVF) Arm 2
Harvesting subcutaneous tSVF with sterile, disposable microcannula system

Treatment: Other: PRP Concentrate Arm 2
Preparation of PRP Concentrate via sterile Terumo-Harvest System

Treatment: Surgery: Cellular Stromal Vascular Fraction (cSVF) Arm 2
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

Treatment: Surgery: Cellular Stromal Vascular Fraction (cSVF) Arm 3
Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)

Treatment: Drugs: Sterile Normal Saline (IV Solution)
Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Other
Intervention code [3] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participant with Complications
Timepoint [1] 0 0
6 Months
Primary outcome [2] 0 0
Numeric Pain Rating Scale (NPRS)
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Changes from Baseline visual analog pain scale (VAS)
Timepoint [3] 0 0
Baseline, 1 month, 6 months, 1 year
Primary outcome [4] 0 0
Changes in Ultrasound Images from Baseline Condition
Timepoint [4] 0 0
Baseline, 6 months, 1 year
Secondary outcome [1] 0 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [1] 0 0
Baseline; 6 Month; 1 year
Secondary outcome [2] 0 0
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Timepoint [2] 0 0
Baseline; 6 Month; 1 Year
Secondary outcome [3] 0 0
Hip Disability and OA Outcomes Survey (HOOS)
Timepoint [3] 0 0
Baseline; 6 Month; 1 Year
Secondary outcome [4] 0 0
Disabilities of the Arm, Shoulder, and Hand Score (DASH)
Timepoint [4] 0 0
Baseline; 6 Month; 1 Year
Secondary outcome [5] 0 0
Roland-Morris Back Pain Questionnaire (RMBPQ)
Timepoint [5] 0 0
Baseline; 6 months; 1 year
Secondary outcome [6] 0 0
Foot and Ankle Ability Measure (FAAM)
Timepoint [6] 0 0
Baseline; 6 Month; 1 Year
Secondary outcome [7] 0 0
Foot and Ankle Disability Index (FADI)
Timepoint [7] 0 0
Baseline; 6 Month; 1 Year

Eligibility
Key inclusion criteria
* Documented osteoarthritic inflammatory and/or degenerative changes in the joint or connective tissues of the knee, hip, shoulder, Achilles tendon, Sacroiliac Joint, wrist/hand, foot/ankle, or Plantar Fasciitis (PR);
* No systemic disorders which, in opinion of principal investigator, would disqualify from safely being able to undergo the determined procedures;
* Have the ability to understand and accept all items in Informed Consent Document;
* Have adequate perivascular and extracellular matrix donor tissues available;
* Mature enough to tolerate determined procedures and follow up instructions and complete post-treatment tracking responsibilities
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Systemic or psychological impairment which would preclude patient tolerance and understanding nature and extent of procedures and follow up tracking;
* Known active cancer, chemotherapy, or radiation therapy;
* Pregnancy;
* Active infections which would increase risk of patient to undergo treatment;
* High dose steroid users, or recipients of corticosteroids with a six month period before treatment date;
* Medication or Opiate addition, or in active treatment for drug rehabilitation;
* History of documented severe traumatic brain injuries;
* In the opinion of the principal investigator/provider, the patient's condition or medical issues which would not allow the individual to fully accomplish or complete the study requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Montana

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Healeon Medical Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Donna Alderman, DO
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Robert W. Alexander, MD
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Donna Alderman, DO
Address 0 0
Country 0 0
Phone 0 0
1 661 295 1110
Fax 0 0
Email 0 0
hemwallcenter@prolotherapy.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Alexander RW. Biocellular Regenerative Medicine: U... [More Details]
Journal Nelson AE, Allen KD, Golightly YM, Goode AP, Jorda... [More Details]
Journal Alderman, D, Alexander, RW, Stem Cell Prolotherapy... [More Details]
Journal Alexander, RW, Overview of Cellular Stromal Vascul... [More Details]
Journal Burdett N, McNeil JD. Difficulties with assessing ... [More Details]
Journal Thorlund JB, Juhl CB, Roos EM, Lohmander LS. Arthr... [More Details]
Journal Katz JN, Brownlee SA, Jones MH. The role of arthro... [More Details]
Journal Alderman, D, Alexander, RW. Advances In Regenerati... [More Details]
Journal Alexander, RW. Understanding Adipose-Derived Strom... [More Details]
Journal Gallagher S, Heberger JR. Examining the interactio... [More Details]
Journal Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Bie... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT04238143