Diabetes MellitusNCT06764719
Cryopreserved Hair Follicles for Disease and Cell Replacement
An observational study of Diabetes Mellitus and Sport Injury, run by Acorn Biolabs Inc. at 1 site in Canada.
Trial summary
To explore the application of cells expanded from plucked hair follicles after collection, transport, and cryopreservation, in disease modeling and cell-based therapies. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Sport Injury, Injury Traumatic
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Acorn Biolabs
Toronto, Quebec, M5R 0C7
Drew Taylor, MSc, PhD, 226-929-8476, info@acorn.me
About this study
Official title: 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.
Read the 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).
- Conditions
- Diabetes Mellitus, Sport Injury, Injury Traumatic
- Keywords
- Hair follicles, stem cells, pluripotent, cell differentiation
- Medical subject headings
- Diabetes Mellitus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hair Follicle Donors | Healthy individuals, aged 18-80, who will have hair follicles collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start6 Jan 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acorn Biolabs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764719
- Sponsor's protocol ID
- 24-003
- Other IDs
- Company Sponsored
- Status last verified
- Oct 2026
- First submitted
- 3 Jan 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Cryopreserved Plucked Hair Follicles and Generation of Functional Cell Lines for Disease Modeling and Cell Replacement Therapies
- ClinicalTrials.gov ID
- NCT06764719
- Acronym / sponsor ID
- 24-003
- Conditions
- Diabetes Mellitus, Sport Injury, Injury Traumatic
- Keywords
- Hair follicles, stem cells, pluripotent, cell differentiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Acorn Biolabs Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the application of cells expanded from plucked hair follicles after collection, transport, and cryopreservation, in disease modeling and cell-based therapies.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hair Follicle Donors | – | –Healthy individuals, aged 18-80, who will have hair follicles collected |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize primary cellular outgrowth(s)
Time frame: 30 days
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.
Evaluate functional stem cell generation and induced pluripotent stem cell line(s) from primary outgrowth(s)
Time frame: 21 days
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.
Evaluate and characterize differentiation of stem cell lines into functional cell types required for various disease states and cell-based application(s)
Time frame: 30 days
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Sport Injury, run by Acorn Biolabs Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Drew Taylor, MSc, PhD (226-929-8476, info@acorn.me), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize primary cellular outgrowth(s) (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.