adipose-derived stem cell injection for Osteoarthritis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sanford USD Medical Center, Sioux Falls, SDOsteoarthritisadipose-derived stem cell injection - Device
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to treat wrist osteoarthritis by injecting ADRCs generated by the Transpose RT system. The trial will compare the safety and efficacy of this new treatment to a standard treatment.

Eligible Conditions
  • Osteoarthritis of the Wrist

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 3, 6 and 12 months

12 months
Safety - Incidence of Treatment-Emergent Adverse Events
Month 12
Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits
Efficacy - Change in Function Scores on the QuickDASH at All Follow-up
Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits

Trial Safety

Trial Design

2 Treatment Groups

Corticosteroid group
1 of 2
Adipose Derived Regenerative Cell group
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: adipose-derived stem cell injection · No Placebo Group · N/A

Adipose Derived Regenerative Cell group
Device
Experimental Group · 1 Intervention: adipose-derived stem cell injection · Intervention Types: Device
Corticosteroid group
Drug
ActiveComparator Group · 1 Intervention: Corticosteroid injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6 and 12 months

Who is running the clinical trial?

InGeneron, Inc.Lead Sponsor
8 Previous Clinical Trials
749 Total Patients Enrolled
1 Trials studying Osteoarthritis
40 Patients Enrolled for Osteoarthritis
Sanford HealthOTHER
44 Previous Clinical Trials
61,914 Total Patients Enrolled
2 Trials studying Osteoarthritis
290 Patients Enrolled for Osteoarthritis
Robert Vandermark, MDPrincipal InvestigatorSanford Health

Eligibility Criteria

Age 18 - 75 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have symptoms that match wrist osteoarthritis.

Who else is applying?

What state do they live in?
Texas100.0%
What site did they apply to?
HD Research100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

Is there an opportunity to partake in this clinical research?

"In order to qualify for this medical trial, individuals must possess a diagnosis of arthrosis and be within the age range of 18-75. A total of 40 patients are required by researchers." - Anonymous Online Contributor

Unverified Answer

Are there any open opportunities for participants in this clinical investigation?

"According to clinicaltrials.gov, the recruitment of participants for this medical trial is ongoing with the initial posting date being November 21st 2018 and last update being August 2nd 2022." - Anonymous Online Contributor

Unverified Answer

How many people are participating in the experiment?

"Affirmative. According to information found on clinicaltrials.gov, this research endeavour is actively recruiting participants with the initial post date of November 21st 2018 and most recent update being August 2nd 2022. At present, they are seeking 40 subjects from two distinct locations." - Anonymous Online Contributor

Unverified Answer

Is the age limit for participation in this research restricted to those below 25?

"This research program is accepting applications from adults aged 18 to 75." - 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.