Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03337243|
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis Knee Pain Chronic Joint Disease Arthritis Osteo Arthritis Knee Musculoskeletal Disease||Procedure: HAM and HUMCWJ Injections||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis|
|Actual Study Start Date :||November 9, 2017|
|Actual Primary Completion Date :||April 26, 2019|
|Actual Study Completion Date :||April 26, 2019|
Experimental: HAM and HUMCWJ Injections (Group 1)
Participants who self-select into the Group 1 (Immediate Treatment) will be scheduled to undergo the HAM and HUMCWJ injections to the OA affected knee at the same visit.
Procedure: HAM and HUMCWJ Injections
SURGENEX SurForce® (1cc) allograft placental based tissue matrix, will be injected using a 22 gauge, 2-inch needle. The injection site (medial, lateral, patellar) will be determined based on the side with the most joint space from the findings of the most recent x-rays. The Physician will insert the needle fully into the joint space and begin to expel the fluid. He will achieve a continuous injection flow as he withdraws the needle back out of joint space. Immediately following the SURGENEX SurForce® injection, an injection of Predictive Biotech CORECYTE(TM) (1 cc) allograft umbilical cord-derived Warton's Jelly tissue matrix will be administered. This will be done using the exact same protocol as the SURGENEX SurForce® injection.
No Intervention: Control (Group 2)
Participants who self-select into Group 2 will choose to delay their HAM and HUMCWJ injection to the OA affected knee for at least 3 months or choose not to have the injections at all. Participants will be asked to keep track of pain management and therapy throughout the 3 months.
- Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months [ Time Frame: Baseline (T0), 4 weeks (T1), 3 months (T2) ]
- Change in pain during sit-to-stand over 3 months [ Time Frame: Baseline (T0), 4 weeks (T1), 3 months (T2) ]Participants will perform as many sit-to-stand movements as they can in 30 seconds and then will rate pain
- Change in pain during supine to upright over 3 months [ Time Frame: Baseline (T0), 4 weeks (T1), 3 months (T2) ]Participants will perform a supine to upright movement as quickly as they can and then will rate pain
- Change in pain during ascent/decent stairs over 3 months [ Time Frame: Baseline (T0), 4 weeks (T1), 3 months (T2) ]Participants will ascend and decent 10 stairs as quickly as they can and then will rate pain
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): NCT03337243
|United States, Pennsylvania|
|Scott Medical Health Center|
|Pittsburgh, Pennsylvania, United States, 15220|