Cryopreserved Hair Follicles for Disease and Cell Replacement

NCT06764719 | Recruiting

• 2 other identifiers: 24-003Company Sponsored
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the application of cells expanded from plucked hair follicles after collection, transport, and cryopreservation, in disease modeling and cell-based therapies.

Conditions

Diabetes Mellitus; Sport Injury; Injury Traumatic

Keywords

Hair follicles; stem cells; pluripotent; cell differentiation

Outcome Measures

Primary Outcomes (3)

• Characterize primary cellular outgrowth(s)

  10 hair follicles will be placed in a tissue culture plate per participants. Over the course of 30 days, the outgrowth percentage (the number of outgrowths present out of 10 will be monitored and the confluency (percent of cells present in relation to surface area) will be noted for each participant.

  30 days

• Evaluate functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s)

  1 million keratinocytes will be taken for reprogramming for each participant. The number of iPS colonies observed on day 21 will be noted, resulting in a reprogramming efficiency score.

  21 days

• Evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s)

  iPS cell lines which have been confirmed to be pluripotent will be differentiated into pancreatic progenitor cells and hematopoietic stem cells. The cells will be analyzed using FLOW cytometry and the percentage of double positive cells will be noted for each participant. This will be repeated for multiple pathways such as the hematopoietic and endothelial lineage(s).

  30 days

Study Arms (1)

Hair Follicle Donors

Healthy individuals, aged 18-80, who will have hair follicles collected

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy population, aged 18-80, without scalp or hair disorders, chronic illnesses that may impact scalp health or wound healing, and not on immunosuppressants, steroids, or medications that cause hair loss.

You may qualify if:

• Gender: Male or Female.
• Age: ≥18 and ≤80 years.
• Language proficiency: Able to read and understand English.
• Informed consent: Willing to provide written, informed consent to participate in all study activities.

You may not qualify if:

• Scalp/Hair Disorders: Subjects diagnosed with active scalp infections or inflammatory skin conditions.
• Systemic Conditions: Subjects with chronic illnesses, such as autoimmune diseases or diabetes, that may impact scalp health or wound healing.
• Medications: Subjects on immunosuppressants, steroids, or other medications associated with hair loss.

Sponsors & Collaborators

• Acorn Biolabs Inc.: lead

Study Sites (1)

Acorn Biolabs

Toronto, Quebec, M5R 0C7, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

hair follicles

MeSH Terms

Conditions

Diabetes Mellitus; Wounds and Injuries

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Drew Taylor, MSc, PhD

CONTACT

226-929-8476; info@acorn.me

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 8, 2025
• Study Start: January 6, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)