---
title: Study of ST266 Versus Saline in Treating Skin Irritation From Radiation
nct_id: NCT01714973
overall_status: COMPLETED
phase: PHASE1
sponsor: Noveome Biotherapeutics, formerly Stemnion
study_type: INTERVENTIONAL
primary_condition: Radiation-induced Dermatitis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01714973.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01714973"
ct_last_update_post_date: 2019-05-13
last_seen_at: "2026-05-12T07:05:14.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

**Official Title:** Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor

**NCT ID:** [NCT01714973](https://clinicaltrials.gov/study/NCT01714973)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Noveome Biotherapeutics, formerly Stemnion
- **Conditions:** Radiation-induced Dermatitis
- **Start Date:** 2012-10
- **Completion Date:** 2015-10
- **CT.gov Last Update:** 2019-05-13

## Brief Summary

The objective of this study is to evaluate the safety and efficacy of ST266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ST266 treated burns with those treated with saline placebo controls.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* A signed IRB - approved Informed Consent;
* Women 18 - 80 years of age;
* Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.
* Whole breast radiation with or without ipsilateral axilla radiation therapy recommended by her radiation oncologist.
* If a woman is of child-bearing potential, she and her partner must use an effective form of birth control.
* Willing to participate in the clinical study and comply with the requirements of the trial.

Exclusion Criteria:

* Abnormal liver or kidney function studies being greater than 2x the upper limit of normal.
* Patients on hemodialysis
* Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to patient compliance;
* History of non-compliance with treatment or clinical visit attendance.
* Participation in an investigational trial within 30 days of study entry.
* Women who are pregnant or lactating
```

## Arms

- **ST266 intact** (EXPERIMENTAL) — Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The first cohort will receive ST266 and saline placebo applied to intact skin beginning immediately following the first radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.
- **ST266 inflamed** (EXPERIMENTAL) — Ten (10) patients will be randomized before the first radiation treatment to receive ST266 (4ml) and saline placebo (4ml), one to the medial segment and the other to the lateral segment. The area of the breast will be divided into two, roughly equal parts, medial and lateral. The randomization scheme will be equal in each of two cohorts. The second cohort will receive ST266 and saline placebo applied to inflamed skin (after inflammation is first noted) beginning immediately following the radiation treatment, to continue immediately following each of ten (10) consecutive radiation treatments.

## Interventions

- **ST266** (BIOLOGICAL) — Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.

## Primary Outcomes

- **Adverse Events (AEs) and Significant Adverse Events (SAEs)** _(time frame: Start of therapy through six week follow-up visit)_

## Secondary Outcomes

- **Skin inflammation** _(time frame: start of therapy through six week follow-up visit)_
- **Quality of Life (QOL)scaled responses** _(time frame: start of therapy through one year follow-up)_

## Locations (1)

- Allegheny General Hospital, Pittsburgh, Pennsylvania, 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.allegheny general hospital|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01714973.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01714973*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*