Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

Study Purpose

This is a prospective, randomized, double-blinded, active controlled, single site safety and efficacy study in subjects suffering from chronic wrist osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the wrist.

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	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Males and females ages: 18

- 75.

2. Clinical symptoms consistent with wrist osteoarthritis. 3. Diagnosed with wrist osteoarthritis on radiographs. 4. The ability of subjects to give appropriate consent or have a legally authorized representative available.

Exclusion Criteria:

1. Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, severe osteoporosis, sepsis and chondrocalcinosis in the wrist. 2. Subjects who have a documented diagnosis of carpal tunnel syndrome. 3. Insufficient amount of subcutaneous tissue to allow recovery of 100ml of lipoaspirate. 4. History of systemic malignant or local neoplasms on affected limb within last 5 years. 5. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.) 6. Subjects who have received a corticosteroid injection in the treatment site. 7. Subjects on an active regimen of chemotherapy. 8. Allergy to sodium citrate of any "caine" type of local anesthetic. 9. Subjects pregnant or breast feeding. 10. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome instruments. 11. Subjects who have document allergy to radiographic guidance agents. 12. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 13. History of tobacco use within the last 3 months. 14. Subjects with documented with a history of alcohol or drug abuse. 15. Subjects who have a documented history of HIV, Hepatitis B, and Hepatitis C. 16. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

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.	NCT03503305
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.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	InGeneron, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robert Vandermark, MD
Principal Investigator Affiliation	Sanford Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis of the Wrist

Additional Details

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.

Arms & Interventions

Arms

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 .

Active Comparator: Corticosteroid group

Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection.

Interventions

Device: - adipose-derived stem cell injection

5 ml injection of adipose derived stem cells

Drug: - Corticosteroid injection

5 ml injection of corticosteroid

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.

Sanford USD Medical Center, Sioux Falls, South Dakota

Status

Active, not recruiting

Address

Sanford USD Medical Center

Sioux Falls, South Dakota, 57105

HD Research, Houston, Texas

Status

Recruiting

Address

HD Research

Houston, Texas, 77041

Site Contact

Mailin Ramirez

[email protected]

713-367-8548

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