Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

InGeneron

Status: Enrolling

Conditions: Osteoarthritis of the Wrist

Treatments: Drug: Corticosteroid injection; Device: adipose-derived stem cell injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03503305

OAW-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Adipose Derived Regenerative Cell group

Experimental group

Description:

Subjects in the treated group will receive an Adipose derived regenerative cells (ADRCs) injection into the wrist using a fluoroscopic-guided injection .

Treatment:

Device: adipose-derived stem cell injection

Corticosteroid group

Active Comparator group

Description:

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

Treatment:

Drug: Corticosteroid injection