---
title: Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
nct_id: NCT04077190
overall_status: COMPLETED
phase: NA
sponsor: InGeneron, Inc.
study_type: INTERVENTIONAL
primary_condition: Rotator Cuff Tears
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04077190.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04077190"
ct_last_update_post_date: 2022-08-03
last_seen_at: "2026-05-12T06:05:38.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

**Official Title:** Extension Study of Protocol RC-001b- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears

**NCT ID:** [NCT04077190](https://clinicaltrials.gov/study/NCT04077190)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** InGeneron, Inc.
- **Conditions:** Rotator Cuff Tears
- **Start Date:** 2019-08-01
- **Completion Date:** 2021-12-01
- **CT.gov Last Update:** 2022-08-03

## Brief 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.

## Detailed Description

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after the administration of a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear compared to the administration of a single corticosteroid injection into the associated subacromial space.

The ADRC mixture is generated from the Transpose® RT System, a point-of-care solution for extraction of an autologous regenerative cell mixture from the adipose tissue after a same-day limited liposuction procedure. A pilot clinical study was recently completed using an injection of ADRC compared to a corticosteroid injection for treatment of PTRCTs. Results support the initiation of a pivotal study to study the same.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **adipose-derived stem cell injection** (EXPERIMENTAL) — Ultrasound guided injection of 5cc adipose derived stem cells
- **cortisone injection** (ACTIVE_COMPARATOR) — Ultrasound guided injection of cortisone

## Interventions

- **Adipose-derived stem cells** (DEVICE) — 5cc adipose derived stem cells.
- **cortisone injection** (DEVICE) — cortisone injection

## Primary Outcomes

- **Long term Safety as indicated through adverse event rate between ADSC and TAU arms** _(time frame: at 24 months)_ — Adverse event rate
- **Long term Safety as indicated through adverse event rate between ADSC and TAU arms** _(time frame: at 36 months)_ — Adverse event rate
- **Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires** _(time frame: at 24 months)_ — Short form-36 score compared to baseline (total score = 800)
- **Long term efficacy of pain and function through Short Form-36 Shoulder Score health questionnaires** _(time frame: at 36 months)_ — Short form-36 score compared to baseline (total score = 800)
- **Long term efficacy of pain and function through ASES Shoulder Score health questionnaires** _(time frame: at 24 months)_ — ASES score compared to baseline (total score = 100)
- **Long term efficacy of pain and function through ASES Shoulder Score health questionnaires** _(time frame: at 36 months)_ — ASES score compared to baseline (total score = 100)

## Secondary Outcomes

- **Long term efficacy will be evaluated through MRIs pre- and post-injection for the therapeutic intent to treat a rotator cuff injury: Percentage improvement in tendon tear size and thickness** _(time frame: at 36 months)_

## Locations (2)

- Sanford Orthopedics and Sports Medicine - Fargo, Fargo, North Dakota, United States
- Sanford orthopedics and Sports Medicine - Sioux Falls, Sioux Falls, South Dakota, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sanford orthopedics and sports medicine - fargo|fargo|north dakota|united states` — added _(2026-05-12)_
- `locations.sanford orthopedics and sports medicine - sioux falls|sioux falls|south dakota|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04077190.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04077190*  
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