Cryopreserved Hair Follicles for Disease and Cell Replacement (Hair Follicles)

Characterization of Cryopreserved Plucked Hair Follicles and Generation of Functional Cell Lines for Disease Modeling and Cell Replacement Therapies

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Sport Injury; Injury Traumatic

Detailed Description

Hair Follicles collected and transported in Acorn's proprietary transport media can serve has therapeutic starting materials for future cell-based therapeutics. This study is to characterize primary cell outgrowth, functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s) as well as evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Drew Taylor, MSc, PhD; Phone Number: 226-929-8476; Email: info@acorn.me

Study Locations

• Canada
  • Quebec
    • Toronto, Quebec, Canada, M5R 0C7
      • Recruiting
      • Acorn Biolabs
      • Contact: Drew Taylor, MSc, PhD; Phone Number: 226-929-8476; Email: info@acorn.me

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hair Follicle Donors; Healthy individuals, aged 18-80, who will have hair follicles collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Acorn Biolabs Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: stem cells; cell differentiation; Hair follicles; pluripotent
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Wounds and Injuries; Diabetes Mellitus
• Other Study ID Numbers: 24-003; Company Sponsored (Other Identifier: Acorn Biolabs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No