Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05079035 |
Recruitment Status :
Active, not recruiting
First Posted : October 15, 2021
Last Update Posted : April 10, 2024
|
Sponsor:
Tissue Tech Inc.
Information provided by (Responsible Party):
Tissue Tech Inc.
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | September 22, 2021 | ||||
First Posted Date ICMJE | October 15, 2021 | ||||
Last Update Posted Date | April 10, 2024 | ||||
Actual Study Start Date ICMJE | December 6, 2021 | ||||
Estimated Primary Completion Date | July 19, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Pain Relief and/or Functional Improvement [ Time Frame: 12-weeks post Intra-articular Injection ] Proportion of subjects who, at the end of 12 weeks, report improvement from baseline in pain or in function > or = 50% and absolute change > or = 20;
- or -
Improvement in at least 2 of the 3 following:
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord (TTAX03) for KL Grade 3-4 Knee OA | ||||
Official Title ICMJE | A Phase 2, 52-Week Trial of TTAX03 vs. Saline as a Single Intra-articular Injection in Kellgren-Lawrence Grade 3-4 Knee OA | ||||
Brief Summary | It is hypothesized that a single Intra-articular Injection of TTAX03, 100mg in 2mL of saline, will have more benefit with respect to the proportion of responders 12 weeks post-injection than an equal volume of saline, based on the OMERACT-OARSI responder criteria. | ||||
Detailed Description | This trial is designed as a Phase 2 randomized, placebo controlled, double-blinded parallel design to be conducted at multiple sites throughout North America. One dose level of TTAX03 (100 mg) will be tested against an equal volume of saline, which is the suspension vehicle (i.e., excipient). Each subject will receive a single IA injection into the knee under local anesthesia, with two safety follow-up visits in the first eight days and a third at the end of two weeks post injection. Subsequent visits will occur at the end of 6 and 12 weeks for evaluation of response, with the end of 12 weeks being the primary endpoint. Additional visits will occur at 6, 9 and 12 months (end of weeks 26, 39, 52) to evaluate duration of benefit and overall impression of change from baseline, as well as safety. The primary endpoint will be assessed at 12 weeks post receiving the assigned Intra-articular injection. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
90 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 1, 2025 | ||||
Estimated Primary Completion Date | July 19, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 35 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05079035 | ||||
Other Study ID Numbers ICMJE | TTAX03-CR005 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | Tissue Tech Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Tissue Tech Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Tissue Tech Inc. | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |