Healing Osteoarthritic Joints in the Wrist With Adult ADRCs
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|ClinicalTrials.gov Identifier: NCT03503305|
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Wrist||Device: adipose-derived stem cell injection Drug: Corticosteroid injection||Not Applicable|
The focus of this study is to investigate the therapeutic benefit of autologous adipose-derived regenerative cells in patients with wrist arthritis. The hypothesis of this trial is that the use of adult-adipose derived regenerative cells as a treatment of wrist arthritis will induce healing and decrease pain compared to the control group. With adult-adipose derived regenerative cell administration, the medical practitioner would anticipate a reduction in inflammation, acceleration in healing, decreased pain in patients post procedure, and increased function and strength in the affected wrist. Currently, no clinical studies have been constructed to determine the efficacy of ADRCs in wrist arthritis patients.
Subjects will fall into two categories: treatment group (20) and control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive wrist osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the wrist. The control group will receive a 5 ml cortisone injection into the wrist.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||It is a double-blinded trial in which the subjects, investigator and radiologists are blinded to treatment assignment.|
|Official Title:||Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells|
|Estimated Study Start Date :||August 31, 2018|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: Adipose Derived Regenerative Cell group
Subjects in the treated group will receive an Adipose derived regenerative cells (ADRCs) injection into the wrist using a fluoroscopic-guided injection .
Device: adipose-derived stem cell injection
5 ml injection of adipose derived stem cells
Active Comparator: Corticosteroid group
Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection.
Drug: Corticosteroid injection
5 ml injection of corticosteroid
- Safety - Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]Subjects will be monitored for adverse events
- Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits [ Time Frame: 3, 6 and 12 months ]Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)
- Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits [ Time Frame: 3, 6 and 12 months ]Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty)
- Efficacy - Change in Function Scores on the QuickDASH at All Follow-up [ Time Frame: 3, 6 and 12 months ]Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503305
|United States, South Dakota|
|Sanford USD Medical Center||Recruiting|
|Sioux Falls, South Dakota, United States, 57105|
|Contact: Amanda Mensing, CCRC 605-312-6444 Amanda.mensing@SanfordHealth.org|
|Contact: Central Referral Line 877-878-4825|
|Principal Investigator:||Robert Vandermark, MD||Sanford Health|