Adipose-derived Stem Cells to Treat Chronic Wounds.

NCT05797688 | Withdrawn Phase 1

• 1 other identifier: 15586
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine whether autologous, adipose-derived regenerative cells improve the healing of chronic wounds. Ten patients will undergo fat harvest and peri-wound injection of the isolated cells in addition to the standard of care for the treatment of their chronic wound. Wound healing will be followed over 24 weeks.

Conditions

Wound of Skin

Keywords

Chronic Wound; Chronic Ulcer; stem cell

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by weekly evalutation of the occurrence of wound infection, redness, swelling, pain, fever, chills, bleeding, and wound healing.

  1 year

Secondary Outcomes (2)

• Complete wound healing

  1 year

• Time to healing

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Patients will undergo a fat harvest procedure and the tissue will then be processed by The Celution System to isolate a 5 mL aliquot including stem cells. This will then be injected into the base and within in perimeter of the target wound.

Device: The Celution System

Interventions

The Celution System DEVICE

The Celution System will isolate regenerative cells, including stem cells, from fat harvested from the treatment patients.

Also known as: Celution, Adipose-derived cell processor

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must agree to adhere to all protocol procedures and return for weekly scheduled wound assessment visits, including requirements for taking and abstaining from medications.
• Subject is willing and able to read, understand and sign a written Informed Consent to participate in the study or have an appropriate representative available to do so.
• Subject must have a full thickness Stage III or Stage IV pressure ulcer, deep venous ulcer, deep diabetic ulcer, ischemic ulcer, abdominal wound, nonhealing surgical site or sickle cell ulcer. For subjects with more than one wound that meet these criteria, the largest qualifying wound will be treated.
• Subject has adequate (\>200 mL) abdominal or other subcutaneous adipose tissue accessible by syringe-based fat harvest and is able to undergo a fat harvest procedure in the opinion of the investigator or per facility guidelines and has activated platelet thromboplastin time (aPTT) within the normal reference range at the time of the fat harvest procedure and no contraindication to fat harvest.
• Subject's wound has been refractory to standard of care (no objective/measureable signs of healing) for at least 30 days.

You may not qualify if:

• Subject has local infection with erythema \> 2 cm, or involving structures deeper than skin and subcutaneous tissues (e.g., abscess, osteomyelitis, septic arthritis, fasciitis), or associated with local wound complications such as prosthetic materials or protruding surgical hardware.
• Subject has ≥ 2 of the following signs of systemic inflammatory response syndrome (SIRS) or septic shock within 7 days of screening:
• Temperature \> 38°C or \< 36°C
• Heart rate \> 90 beats/min
• Respiratory rate \> 20 breaths/min or PaCO2 \< 32 mm Hg
• White blood cell count \> 12,000 or \< 4,000 cells/μL or ≥ 10% immature (band) forms.
• Subject has received biologic or cell therapy within 12 weeks of initiation of the study.
• Subject not eligible for syringe-based liposuction of at least 200 mL of subcutaneous adipose tissue, including therapeutic anticoagulation with INR \>1.7 or PTT \>60, or receiving GIIb/IIIa inhibitors within 2 weeks prior to the study.
• Subject has squamous cell carcinoma, basal cell carcinoma, melanoma or skin carcinoma of the affected limb or area and underwent treatment within the last year.
• Subject is pregnant as determined by a positive pregnancy test prior to procedure, or breast-feeding.
• Clinically significant abnormal findings on laboratory screening panels, including hemoglobin ≤10 g/dL.
• Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine aminotranferase (ALT), or bilirubin level \> 1.5 times the upper limit of normal range (x ULN) prior to randomization.
• Chronic renal insufficiency as defined as a serum creatinine \> 2.0 mg/dL or requires dialysis.
• History of organ transplantation.

Sponsors & Collaborators

• Winthrop University Hospital: lead
• Cytori Therapeutics: collaborator

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Study Officials

• Harold Brem, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: April 4, 2023
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 4, 2023

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)