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Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503305
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : March 16, 2023
Sponsor:
Collaborator:
Sanford Health
Information provided by (Responsible Party):
InGeneron, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Wrist Device: adipose-derived stem cell injection Drug: Corticosteroid injection Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: It is a double-blinded trial in which the subjects, investigator and radiologists are blinded to treatment assignment.
Primary Purpose: Treatment
Official Title: Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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 .
 Device: adipose-derived stem cell injection
5 ml injection of adipose derived stem cells
Active Comparator: Corticosteroid group
Subjects in the active control group will receive a corticosteroid injection into the wrist using a fluoroscopic-guided injection.
 Drug: Corticosteroid injection
5 ml injection of corticosteroid


Outcome Measures
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Primary Outcome Measures :
  1. Safety - Incidence of Treatment-Emergent Adverse Events [ Time Frame: 12 months ]
    Subjects will be monitored for adverse events


Secondary Outcome Measures :
  1. Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits [ Time Frame: 3, 6 and 12 months ]
    Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)

  2. Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits [ Time Frame: 3, 6 and 12 months ]
    Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty)

  3. Efficacy - Change in Function Scores on the QuickDASH at All Follow-up [ Time Frame: 3, 6 and 12 months ]
    Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503305


Locations
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United States, South Dakota
Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Sanford health    605-312-6020    stemcelltherapy@sanfordhealth.org   
United States, Texas
HD Research Recruiting
Houston, Texas, United States, 77041
Contact: Mailin Ramirez    713-367-8548    mdramirez@ergclinical.com   
Principal Investigator: Daneshvari Solanki, MD         
Sponsors and Collaborators
InGeneron, Inc.
Sanford Health
Investigators
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Principal Investigator: Robert Vandermark, MD Sanford Health
More Information
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Publications:

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Responsible Party: InGeneron, Inc.
ClinicalTrials.gov Identifier: NCT03503305    
Other Study ID Numbers: OAW-001
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by InGeneron, Inc.:
Adipose-derived stem cells
osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases