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Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

Primary Purpose

Osteoarthritis of the Wrist

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

adipose-derived stem cell injection

Corticosteroid injection

About this trial

This is an interventional treatment trial for Osteoarthritis of the Wrist focused on measuring Adipose-derived stem cells, osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanford USD Medical CenterRecruiting
HD ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adipose Derived Regenerative Cell group

Corticosteroid group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety - Incidence of Treatment-Emergent Adverse Events

Subjects will be monitored for adverse events

Secondary Outcome Measures

Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits

Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)

Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits

Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty)

Efficacy - Change in Function Scores on the QuickDASH at All Follow-up

Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable)

Full Information

NCT ID

NCT03503305

First Posted

April 5, 2018

Last Updated

March 15, 2023

Sponsor

InGeneron, Inc.

Collaborators

Sanford Health

1. Study Identification

Unique Protocol Identification Number

NCT03503305

Brief Title

Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

Official Title

Healing Osteoarthritic Joints in the Wrist With Adult Adipose Derived Regenerative Cells

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 21, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InGeneron, Inc.

Collaborators

Sanford Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Wrist

Keywords

Adipose-derived stem cells, osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

It is a double-blinded trial in which the subjects, investigator and radiologists are blinded to treatment assignment.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adipose Derived Regenerative Cell group

Arm Type

Experimental

Arm Description

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

Arm Title

Corticosteroid group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

adipose-derived stem cell injection

Intervention Description

5 ml injection of adipose derived stem cells

Intervention Type

Drug

Intervention Name(s)

Corticosteroid injection

Intervention Description

5 ml injection of corticosteroid

Primary Outcome Measure Information:

Title

Safety - Incidence of Treatment-Emergent Adverse Events

Description

Subjects will be monitored for adverse events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Efficacy - Change in Pain Scores on the Visual Analog Scale (VAS)-pain Scale at All Follow-up Visits

Description

Patient outcomes for pain will be recorded (line from 0: no pain to 100:worst pain)

Time Frame

3, 6 and 12 months

Title

Efficacy - Change in Function Scores on the PROMIS at All Follow-up Visits

Description

Patient outcomes for function will be recorded (line from 0:unable to do to 100: without any difficulty)

Time Frame

3, 6 and 12 months

Title

Efficacy - Change in Function Scores on the QuickDASH at All Follow-up

Description

Patient outcomes for function will be recorded (line from 0:no difficulty to 100:unable)

Time Frame

3, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Vandermark, MD

Organizational Affiliation

Sanford Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanford USD Medical Center

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sanford health

Phone

605-312-6020

stemcelltherapy@sanfordhealth.org

Facility Name

HD Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77041

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mailin Ramirez

Phone

713-367-8548

mdramirez@ergclinical.com

First Name & Middle Initial & Last Name & Degree

Daneshvari Solanki, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17495232

Citation

Gimble JM, Katz AJ, Bunnell BA. Adipose-derived stem cells for regenerative medicine. Circ Res. 2007 May 11;100(9):1249-60. doi: 10.1161/01.RES.0000265074.83288.09.

Results Reference

background

PubMed Identifier

22961401

Citation

ter Huurne M, Schelbergen R, Blattes R, Blom A, de Munter W, Grevers LC, Jeanson J, Noel D, Casteilla L, Jorgensen C, van den Berg W, van Lent PL. Antiinflammatory and chondroprotective effects of intraarticular injection of adipose-derived stem cells in experimental osteoarthritis. Arthritis Rheum. 2012 Nov;64(11):3604-13. doi: 10.1002/art.34626.

Results Reference

background

PubMed Identifier

24449146

Citation

Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634. Erratum In: Stem Cells. 2017 Jun;35(6):1651-1652.

Results Reference

background

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Healing Osteoarthritic Joints in the Wrist With Adult ADRCs

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