Cellular Stromal Vascular Fraction (cSVF) Arm 2 for Osteoarthritis

Phase-Based Progress Estimates
Hemwall Center for Orthopedic Regenerative Medicine, Valencia, CAOsteoarthritis+5 MoreCellular Stromal Vascular Fraction (cSVF) Arm 2 - Procedure
18 - 90
All Sexes
What conditions do you have?

Study Summary

This trial is studying a new way to treat osteoarthritis by using a person's own stem cells and growth factors.

Eligible Conditions
  • Osteoarthritis
  • Osteoarthritis of the Knee
  • Osteoarthritis of the Hip
  • Shoulder Osteoarthritis
  • Osteoarthritis of the Ankle/Foot

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: Baseline, 1 month, 6 months, 1 year

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

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

tSVF + PRP + cSVF Arm 2
1 of 3
tSVF + PRP Arm1
1 of 3
Normal Saline IV + cSVF Arm 3
1 of 3

Experimental Treatment

100 Total Participants · 3 Treatment Groups

Primary Treatment: Cellular Stromal Vascular Fraction (cSVF) Arm 2 · No Placebo Group · N/A

tSVF + PRP + cSVF Arm 2Experimental Group · 3 Interventions: Tissue Stromal Vascular Fraction (tSVF) Arm 2, PRP Concentrate Arm 2, Cellular Stromal Vascular Fraction (cSVF) Arm 2 · Intervention Types: Procedure, Biological, Procedure
tSVF + PRP Arm1Experimental Group · 2 Interventions: PRP Concentrate Arm 1, Tissue Stromal Vascular Fraction (tSVF) Arm 1 · Intervention Types: Biological, Procedure
Normal Saline IV + cSVF Arm 3Experimental Group · 2 Interventions: Cellular Stromal Vascular Fraction (cSVF) Arm 3, Sterile Normal Saline (IV Solution) · Intervention Types: Procedure, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month, 6 months, 1 year

Who is running the clinical trial?

Healeon Medical IncLead Sponsor
8 Previous Clinical Trials
610 Total Patients Enrolled
Donna Alderman, DOUNKNOWN
Robert W. Alexander, MDUNKNOWN
3 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18 - 90 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
Regenevita LLC100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
How many prior treatments have patients received?

Frequently Asked Questions

Are my characteristics compatible with the criteria to participate in this experiment?

"For this osteoarthritis research project, 100 individuals aged 18 to 90 are being sought. Candidates must be free of systemic disorders which could jeopardise their safety; have ample donor tissue around their blood vessels and extracellular matrixes; and possess the maturity necessary to abide by treatment plans as well as fulfil post-treatment tracking requirements." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial actively enrolling participants?

"Confirmed, this medical study is still seeking participants. It has been listed on clinicaltrials.gov since January 10th 2020 and was last revised in April of 2022." - Anonymous Online Contributor

Unverified Answer

What outcomes is this medical research attempting to demonstrate?

"The primary aim of this research is to evaluate the effect of Participant with Complications over Baseline, 6 months and 1 year. Secondary goals encompass assessing Foot and Ankle Disability Index (FADI) for changes in disability caused by pain and function; Knee Injury & Osteoarthritis Outcome Score (KOOS) determining knee health through gauging levels of pain from osteoarthritis; as well as Foot & Ankle Ability Measure (FAAM), which monitors shifts in discomfort, range-of-motion, and performance." - Anonymous Online Contributor

Unverified Answer

Is there an age limit to participation in this experiment?

"This research protocol is open to any individuals aged 18 and below 90." - Anonymous Online Contributor

Unverified Answer

How many people have enrolled in this medical experiment?

"Yes, the pertinent data hosted on clinicaltrials.gov confirms that recruitment for this medical study is ongoing. The information was initially posted on October 1st 2020 and most recently updated on April 7th 2022. This experiment necessitates the enrolment of 100 individuals at two distinct sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.