CompletedNot Applicable

Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

United States15 participantsStarted 2019-08-01

Plain-language summary

Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.

Who can participate

Age range30 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient completed participation in RC-001 (NCT02918136) study * Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial. Exclusion Criteria: * none

What they're measuring

Long term Safety as indicated through adverse event rate between ADSC and TAU arms

Timeframe: at 24 months

Long term Safety as indicated through adverse event rate between ADSC and TAU arms

Timeframe: at 36 months

Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires

Timeframe: at 24 months

Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires

Timeframe: at 36 months

Long term efficacy of pain and function through ASES Shoulder Score health questionnaires

Timeframe: at 24 months

Long term efficacy of pain and function through ASES Shoulder Score health questionnaires

Timeframe: at 36 months

Trial details

NCT IDNCT04077190

SponsorInGeneron, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-01

View on ClinicalTrials.gov More Rotator Cuff Tears trials