Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

Last updated: April 4, 2024
Sponsor: InGeneron, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Treatment

adipose-derived stem cell injection

Corticosteroid injection

Clinical Study ID

NCT03503305
OAW-001
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 authorizedrepresentative available.

Exclusion

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 orsevere autoimmune disease that requires chronic immunosuppressive therapy (e.g., humanimmunodeficiency 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 therequirements of the study protocol or is unsuitable for the study for any reason. Thisincludes 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 yetcompleted 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, adversepersonal circumstances or lack of autonomy. This may include: Individuals with mentaldisability, persons in nursing homes, children, impoverished persons, persons inemergency situations, homeless persons, nomads, refugees, and those incapable ofgiving informed consent. Vulnerable populations also may include members of a groupwith a hierarchical structure such as university students, subordinate hospital andlaboratory personnel, employees of the Sponsor, members of the armed forces, andpersons kept in detention.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: adipose-derived stem cell injection
Phase:
Study Start date:
November 21, 2018
Estimated Completion Date:
March 31, 2025

Study Description

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.

Connect with a study center

  • Sanford USD Medical Center

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • HD Research

    Houston, Texas 77041
    United States

    Active - Recruiting

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