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. 2016 May 26;2016(5):CD007628. doi: 10.1002/14651858.CD007628.pub4

NCT01451021.

Methods This is a investigator‐blind RCT
Participants Inclusion criteria
  • 21 male and female volunteers 18 to 65 years old, inclusive.

  • Hair loss consistent with ≥ Grade III‐Vertex, IV, VA, V, and VI, based on Norwood‐Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.

  • Have no clinically significant disease or abnormal laboratory results taken at the screening visit.


Exclusion criteria
  • Known sensitivity to DMEM/F‐12 or any component of the study material.

  • Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.

  • Participants who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.

  • A history of drug or alcohol abuse within 1 year of study enrolment.

  • Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.

  • Any clinically significant abnormal laboratory parameters.

  • A positive result at screening for HIV 1 or 2, Hepatitis B or C, HTLV I/II.

  • Dermatological condition in donation or study areas, or both.

  • Prior surgery in the treatment area.

  • Insufficient hair or scarring in the donor area that might impact cell growth.

  • Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematological, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system (CNS) function; or any condition that would place the participant at increased risk.

Interventions
  • A piece of occipital scalp is taken from the participant. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original participant.

  • Dermal cells only.

Outcomes Primary outcomes
  • Change from baseline in hair number.

  • Change from baseline in hair width.

  • Time course of any treatment benefit.

Notes We accessed the website on 4 August 2015, which was last updated on 28 February 2012. The study has been completed