Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    40
  • sponsor
    InGeneron, Inc.
Updated on 9 August 2022

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.

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.

Details
Condition Osteoarthritis of the Wrist
Treatment Corticosteroid Injection, Adipose-derived stem cell injection
Clinical Study IdentifierNCT03503305
SponsorInGeneron, Inc.
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females ages: 18 - 75
Clinical symptoms consistent with wrist osteoarthritis
Diagnosed with wrist osteoarthritis on radiographs
The ability of subjects to give appropriate consent or have a legally authorized representative available

Exclusion Criteria

Subjects who have a documented history or presence of inflammatory arthritis, rheumatoid arthritis, severe osteoporosis, sepsis and chondrocalcinosis in the wrist
Subjects who have a documented diagnosis of carpal tunnel syndrome
Insufficient amount of subcutaneous tissue to allow recovery of 100ml of lipoaspirate
History of systemic malignant or local neoplasms on affected limb within last 5 years
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.)
Subjects who have received a corticosteroid injection in the treatment site
Subjects on an active regimen of chemotherapy
Allergy to sodium citrate of any "caine" type of local anesthetic
Subjects pregnant or breast feeding
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
Subjects who have document allergy to radiographic guidance agents
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
History of tobacco use within the last 3 months
Subjects with documented with a history of alcohol or drug abuse
Subjects who have a documented history of HIV, Hepatitis B, and Hepatitis C
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
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