← Back to Search

Biological

Micronized DHACM Injection for Knee Osteoarthritis

Phase 2
Waitlist Available
Research Sponsored by MiMedx Group, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days, 60 days, 90 days, 120 days, 150 days, 270 days, 365 days
Awards & highlights

Study Summary

This trial tests two doses of a new injection to treat knee osteoarthritis to see if it's safe and effective compared to a placebo.

Who is the study for?
Adults aged 21-80 with primary knee osteoarthritis (OA) for at least 6 months, experiencing moderate pain despite trying two standard treatments. Participants must have a specific level of OA severity on X-rays and be willing to stop current pain medications except acetaminophen. They should not have severe knee issues like locking or infections, other major joint pains, autoimmune diseases, recent surgeries in the affected knee, or use certain drugs that could affect the trial.Check my eligibility
What is being tested?
The trial is testing two doses of micronized DHACM injectable (40 mg and 100 mg) against a saline placebo to see if they are safe and effective for treating knee OA. The goal is to find out which treatment helps reduce pain and improve function better than just getting a saltwater shot.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site such as pain or swelling, allergic responses due to sensitivity to components in the injectable product including antibiotics present in it, and general discomfort. Specific side effects will be monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days, 60 days, 90 days, 120 days, 150 days, 270 days, 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 60 days, 90 days, 120 days, 150 days, 270 days, 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in WOMAC function subscale score between baseline and Day 180
Change in WOMAC pain subscale score between baseline and Day 180
Proportions of subjects who report treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Secondary outcome measures
Change in SF-36 physical component score (PCS), mental component score (MCS), and domain scores between baseline and Day 90 or Day 180
Change in patient's global assessment (PtGA) of the target joint between baseline and Day 90 or Day 180
Number of OMERACT-OARSI "Strict Responders" at Day 90 or Day 180
+2 more
Other outcome measures
Average amount (milligrams) of rescue medication used between Day 8 and Day 180 and between Day 180 and Day 365
Change in WOMAC function subscale scores between baseline and additional time points
Change in WOMAC pain subscale scores between baseline and additional time points
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Micronized DHACM 40 mgExperimental Treatment1 Intervention
Injection of 40 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP
Group II: Micronized DHACM 100 mgExperimental Treatment1 Intervention
Injection of 100 mg allogeneic micronized dehydrated human amnion chorion membrane (DHACM) suspended in 2.5 mL, 0.9% Sodium Chloride, USP
Group III: SalinePlacebo Group1 Intervention
Injection of 2.5 ml, 0.9% Sodium Chloride, USP

Find a Location

Who is running the clinical trial?

MiMedx Group, Inc.Lead Sponsor
34 Previous Clinical Trials
2,616 Total Patients Enrolled
3 Trials studying Osteoarthritis
663 Patients Enrolled for Osteoarthritis
Rho, Inc.Industry Sponsor
24 Previous Clinical Trials
5,720 Total Patients Enrolled
United BioSource, LLCIndustry Sponsor
14 Previous Clinical Trials
11,531 Total Patients Enrolled

Media Library

Micronized DHACM Injectable Product (Biological) Clinical Trial Eligibility Overview. Trial Name: NCT05796765 — Phase 2
Osteoarthritis Research Study Groups: Micronized DHACM 100 mg, Micronized DHACM 40 mg, Saline
Osteoarthritis Clinical Trial 2023: Micronized DHACM Injectable Product Highlights & Side Effects. Trial Name: NCT05796765 — Phase 2
Micronized DHACM Injectable Product (Biological) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05796765 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research trial extend to participants that are beyond the age of 50?

"This research trial is seeking eligible individuals who have passed their 21st birthday, but are not yet 80."

Answered by AI

Who meets the criteria for participation in this experiment?

"Entrants for this study should be aged between 21 and 80 with a diagnosis of osteoarthritis. 471 participants are currently being sought after to join the trial."

Answered by AI

How does micronized DHACM 40 mg impact patient safety?

"There is preliminary evidence confirming the safety of micronized DHACM 40 mg, so it was assigned a rating of 2. To date, there has yet to be data suggesting its efficacy in treating conditions."

Answered by AI

Are there a number of locations in North America currently conducting the trial?

"Patients for this trial can be recruited from Clintex Research Group, Inc. in Coral Gables, Florida; AppleMed Research Group in Miami, Idaho; Health and Life Research Institute, LLC in The Villages, Illinois; as well as 24 other medical sites across the USA."

Answered by AI

Is enrollment open for this research endeavor?

"Per the clinicaltrials.gov website, this research is actively recruiting participants with a start date of February 17th 2023 and an updated entry on March 21st 2023."

Answered by AI

What is the current enrollment count for this clinical trial?

"Affirmative. According to the clinicaltrials.gov listing, this study is presently seeking participants and was initially published on February 17th 2023 with a recent update made on March 21st of the same year. The trial requires 471 people at 24 different healthcare sites for enrolment."

Answered by AI

What is the objective of this experiment?

"This trial will be evaluating its primary outcome, the change in WOMAC function subscale score over a 6 month period. Secondary efficacy endpoints include assessing the proportion of subjects who report an MCID improvement in pain and functioning compared to baseline at 180 days as well as changes in SF-36 physical component scores and domain scores from day 0 to 90."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
AppleMed Research Group
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Phase 2B Micronized DHACM vs. Saline in the Treatment of Knee Osteoarthritis
2023. "Phase 2B Micronized DHACM vs. Saline in the Treatment of Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05796765.
~21 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top