Micronized dHACM vs. Saline in the Treatment of Osteoarthritis of the Knee

Study Purpose

The purpose of this study is to determine the safety and effectiveness of micronized dehydrated human amnion chorion membrane as compared to the 0.9% Sodium Chloride Injection, USP placebo control for the treatment of knee osteoarthritis

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 21 and ≤ 80 years 2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale 3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study 4. Subject must have a VAS pain scale greater than 45

Exclusion Criteria:

1. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale 2. BMI greater than 40 kg/m2 3. Subject has active infection at the injection site 4. Symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol®) and requires other therapy. 5. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other disorders that is the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer 6. Subject has documented history of gout or pseudo-gout 7. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV 8. Subject has received any of the following to the target knee: 1. Intra-articular hyaluronic acid (HA) injection within 12 weeks prior to screening 2. Steroid or platelet rich plasma (PRP) injection within 12 weeks prior to screening 3. Has had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment 4. History of a total knee arthroplasty 9. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment 10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years 11. Subject has had prior radiation at the site 12. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin) 13. Subject is pregnant or plans to become pregnant within 365 days of treatment 14. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation 15. Subject is a worker's compensation patient 16. Subject is a prisoner

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03485157
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	MiMedx Group, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alfred C Gellhorn, MD
Principal Investigator Affiliation	Weill Cornell Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Osteoarthritis

Arms & Interventions

Arms

Experimental: Micronized dHACM

Injection of micronized dHACM

Placebo Comparator: Saline

Injection of 0.9% Sodium Chloride Injection, USP

Interventions

Biological: - Micronized DHACM

Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP

Drug: - Saline

Injection of 1 mL 0.9% Sodium Chloride, USP

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Central Research Associates, Inc, Birmingham, Alabama

Status

Recruiting

Address

Central Research Associates, Inc

Birmingham, Alabama, 35205

Site Contact

Shellie Tasllie, LPN

Clinical Trial Finder